A Phase 1 interventional study of CPU-YL01 Injection Intramuscular administration and Placebo intramuscular injection in Chronic Hepatitis B, sponsored by Jiangsu Chuangyuan Life Science and Technology Co., Ltd.. Enrolling by invitation at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Jiangsu Chuangyuan Life Science and Technology Co., Ltd. · Phase 1, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1 trial. It aims to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CPU-YL01 injection in chronic hepatitis B patients who have received nucleos(t)ide analog therapy. Single-dose and multiple-dose escalations will be conducted in this study
This study is a multicenter, randomized, double blind, placebo controlled Phase I clinical trial involving single dose and multiple dose, dose-escalation explorations, aimed at evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CPU-YL01 in patients with chronic hepatitis B (CHB) previously treated with nucleos(t)ide analogs (NAs), as well as exploring its effects on biomarkers and immunogenicity, thereby providing a scientific basis for dose selection in Phase II clinical trials. Patients enrolled in this trial must have been previously treated with NAs; during the trial, they shall continue to take their respective NAs at the same regimen including drug class, dosage, and dosing frequency to avoid virological breakthrough due to discontinuation of NAs.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 74 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →This is the only study on the registry with Jiangsu Chuangyuan Life Science and Technology Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects who exhibit significant abnormalities in laboratory tests or (ECG) findings during the screening phase, and whom the investigator determines to be unsuitable for participation in this trial, including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intramuscular administration
Drug: CPU-YL01 Injection Intramuscular administration
Intramuscular administration
Drug: Placebo intramuscular injection
Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
adverse events [Safety and Tolerability Evaluation Endpoints]
adverse events
Time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
serious adverse events [Safety and Tolerability Evaluation Endpoints]
serious adverse events
Time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events of particular concern (AESI) [Safety and Tolerability Evaluation Endpoints]
adverse events of particular concern (AESI)
Time frame: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
vital signs-Blood Pressure (mmHg) [Safety and Tolerability Evaluation Endpoints]
vital signs-Blood Pressure (mmHg)
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-respiratory rate (breaths/min) [Safety and Tolerability Evaluation Endpoints]
vital signs-respiratory rate (breaths/min)
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-body temperature (°C) [Safety and Tolerability Evaluation Endpoints]
vital signs-body temperature (°C)
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-pulse rate (beats/min) [Safety and Tolerability Evaluation Endpoints]
vital signs-pulse rate (beats/min)
Time frame: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
physical examination- skin- Color abnormalities-jaundice -The number of participants with or without skin Color abnormalities- jaundice [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Color abnormalities: jaundice. The number of participants with or without skin Color abnormalities: jaundice will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin- Color abnormalities-pallor- The number of participants with or without skin Color abnormalities: pallor [Safety and Tolerability Evaluation Endpoints]
physical examination- skin- Color abnormalities: pallor. The number of participants with or without skin Color abnormalities: pallor will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities-pigmentation- The number of participants with or without skin Color abnormalities:pigmentation [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Color abnormalities : pigmentation. The number of participants with or without skin Color abnormalities:pigmentation will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities- rash-The number of participants with or without -Morphological abnormalities: rash [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Morphological abnormalities: rash . The number of participants with or without -Morphological abnormalities: rash will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities-erythema at injection site -The number of participants with or without -Morphological abnormalities: erythema at injection site [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Morphological abnormalities: erythema at injection site. The number of participants with or without -Morphological abnormalities: erythema at injection site will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: induration at injection site- The number of participants with or without -Morphological abnormalities: induration at injection site [Safety and Tolerability Evaluation Endpoints]
physical examination- skin-Morphological abnormalities: induration at injection site. The number of participants with or without -Morphological abnormalities: induration at injection site will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Ocular conjunctiva: assessment for scleral icterus- The number of participants with or without -Ocular conjunctiva-scleral icterus [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes- Ocular conjunctiva: assessment for scleral icterus. The number of participants with or without -Ocular conjunctiva-scleral icterus will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Ocular conjunctiva: assessment for conjunctival pallor-The number of participants with or without -Ocular conjunctiva-conjunctival pallor [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Ocular conjunctiva: assessment for conjunctival pallor. The number of participants with or without -Ocular conjunctiva-conjunctival pallor will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for petechiae-The number of participants with or without Oral mucosa-petechiae [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Oral mucosa: assessment for petechiae. The number of participants with or without Oral mucosa-petechiae will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for ulceration-The number of participants with or without Oral mucosa-ulceration [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Oral mucosa: assessment for ulceration. The number of participants with or without Oral mucosa-ulceration will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Oral mucosa: assessment for fungal infection-The number of participants with or without Oral mucosa-fungal infection [Safety and Tolerability Evaluation Endpoints]
physical examination-mucous membranes-Oral mucosa: assessment for fungal infection. The number of participants with or without Oral mucosa-fungal infection will be reported by category.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- lymph nodes enlargement -The number of participants with or without lymph nodes enlargement [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes enlargement. The number of participants with or without lymph nodes enlargement will be reported by category. (Among participants with enlarged lymph nodes, findings for lymph node consistency, mobility and tenderness will also be summarized.)
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- Lymph Node Consistency(Participants with Enlarged Lymph Nodes)- The number of participants with lymph node consistency- soft, firm, hard. [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes- Assessment of lymph node consistency (soft, firm, hard). Among participants with enlarged lymph nodes, lymph node consistency will be assessed (soft, firm, hard). The number of participants in each consistency category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes-assessment for lymph nodes mobility (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node mobility -mobile, fixed. [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes - Assessment of lymph node mobility (mobile / fixed). Among participants with enlarged lymph nodes, lymph node mobility will be assessed (mobile, fixed). The number of participants in each mobility category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes-assessment for tenderness (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node tenderness tender, non-tender. [Safety and Tolerability Evaluation Endpoints]
physical examination-lymph nodes -assessment for tenderness. Among participants with enlarged lymph nodes, assessment for lymph node tenderness (tender, non-tender). The number of participants in each tenderness category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for dull facies-The number of participants with dull facies [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Face: assessment for dull facies. The number of participants with dull facies will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for facial edema-The number of participants with facial edema [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Face: assessment for facial edema. The number of participants with facial edema will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for eyelid edema-The number of participants with eyelid edema [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Eyes: assessment for eyelid edema. The number of participants with eyelid edema will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for pupillary light reflex-The number of participants with normal, abnormal pupillary light reflex [Safety and Tolerability Evaluation Endpoints]
physical examination-head-Eyes: assessment for pupillary light reflex. Assessment of pupillary light reflex (normal / abnormal). The number of participants with normal, abnormal pupillary light reflex will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-assessment for alopecia- The number of participants with alopecia [Safety and Tolerability Evaluation Endpoints]
physical examination-head-assessment for alopecia. The number of participants with alopecia will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid Enlargement- The number of participants with Thyroid Enlargement [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment for Thyroid Enlargement. The number of participants with Thyroid Enlargement will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid nodules-The number of participants with Thyroid nodules [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment for Thyroid nodules. The number of participants with Thyroid nodules will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment of tracheal position-The number of participants with tracheal position midline / deviated [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment of tracheal position (midline / deviated). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for nuchal rigidity-The number of participants with nuchal rigidity [Safety and Tolerability Evaluation Endpoints]
physical examination-neck-assessment for nuchal rigidity. The number of participants with nuchal rigidity will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Lungs: assessment of breath sound clarity-The number of participants with lung breath sounds clear, wheezes, rales. [Safety and Tolerability Evaluation Endpoints]
physical examination- chest-Lungs: Assessment of lung breath sounds (clear, wheezes, rales). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: assessment of cardiac rhythm regularity-The number of participants with cardiac rhythm regular, irregular. [Safety and Tolerability Evaluation Endpoints]
physical examination- chest-Heart: Assessment of cardiac rhythm (regular / irregular). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: assessment of cardiac murmur-The number of participants with cardiac murmur present, absent. [Safety and Tolerability Evaluation Endpoints]
physical examination- chest-Heart: Assessment for cardiac murmur (present / absent). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of Palpability of Liver Edge Below Right Midclavicular Costal Margin-The number of participants with the liver edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Liver. Abdominal palpation to assess whether the liver edge is palpable below the right midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter)(For participants with a palpable liver edge)[Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Liver-Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter). For participants with a palpable liver edge below the right midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable liver edge.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of hepatic consistency-The number of participants with hepatic consistency soft, firm, hard.(For participants with a palpable liver edge) [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Liver: assessment of consistency (soft, firm, hard). Among participants with a palpable liver edge below the costal margin, hepatic consistency is assessed (soft, firm, hard). The number of participants in each consistency category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal wall varices-The number of participants with abdominal wall varices [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-assessment for abdominal wall varices.The number of participants with abdominal wall varices will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal tenderness-The number of participants with abdominal tenderness [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-assessment for abdominal tenderness.The number of participants with abdominal tenderness will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for rebound tenderness-The number of participants with rebound tenderness. [Safety and Tolerability Evaluation Endpoints
physical examination-abdomen-assessment for rebound tenderness. The number of participants with rebound tenderness will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for shifting dullness (indicative of ascites)-The number of participants-shifting dullness for ascites screening positive, negative. [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Percussion assessment for shifting dullness for ascites screening (positive / negative). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen: assessment of Palpability of Spleen Edge Below Left Midclavicular Costal Margin-The number of participants with the splenic edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Spleen-Abdominal palpation to assess whether the splenic edge is palpable below the left midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Spleen: Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter)(For participants with a palpable splenic edge ) [Safety and Tolerability Evaluation Endpoints]
physical examination-abdomen-Spleen- Distance of Palpable Spleen Edge Below the Left Midclavicular Costal Margin (centimeter) .For participants with a palpable splenic edge below the left midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable splenic edge.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema-The number of participants with bilateral lower extremity edema [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for bilateral lower extremity edema. The number of participants with bilateral lower extremity edema will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint erythema-The number of participants with joint erythema [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint erythema.The number of participants with joint erythema will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint warmth -The number of participants with joint warmth [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint warmth. The number of participants with joint warmth will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint tenderness -The number of participants with joint tenderness [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint tenderness. The number of participants with joint tenderness will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: assessment for joint swelling -The number of participants with joint swelling [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for deformity The number of participants with Spine deformity. [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Spine: assessment for deformity. The number of participants with Spine deformity. will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Extremities: Spine: assessment for tenderness -The number of participants withwith Spine tenderness [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Extremities: assessment for joint swelling. The number of participants with joint swelling will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- spine/limbs-Spine: assessment for limited range of motion The number of participants with limited range of motion . [Safety and Tolerability Evaluation Endpoints]
physical examination- spine/limbs-Spine: assessment for limited range of motion. The number of participants with limited range of motion of Spine will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination--assessment of development- The number of participants with development good, fair, poor. [Safety and Tolerability Evaluation Endpoints]
physical examination-assessment of development. General physical examination assessment of development (good, fair, poor).. The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination--assessment of nutritional status- The number of participants with nutritional status good, fair, poor. [Safety and Tolerability Evaluation Endpoints]
physical examination-assessment of nutritional status. Assessment of nutritional status (good, fair, poor). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination--assessment of mental status- The number of participants with mental status alert, drowsy, agitated, comatose. [Safety and Tolerability Evaluation Endpoints]
physical examination-other areas-Assessment of mental status (alert, drowsy, agitated, comatose). The number of participants in each category will be reported.
Time frame: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
12-lead electrocardiogram-heart rate [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-heart rate
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-PR interval [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-PR interval
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-RR interval [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-RR interval
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QRS [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-QRS
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QT interval [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-QT interval
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-QTcF [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-QTcF
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
12-lead electrocardiogram-electrocardiographic diagnostic results [Safety and Tolerability Evaluation Endpoints]
12-lead electrocardiogram-electrocardiographic diagnostic results
Time frame: Single-dose: screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, and Day29. Multiple-dose: screening, on Day-1, Day1,Day2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Clinical laboratory tests-hematology-red blood cell count (RBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-red blood cell count (RBC)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-Concentration of hemoglobin (HGB)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-white blood cell count (WBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-white blood cell count (WBC)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-absolute neutrophil count (ANC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-absolute neutrophil count (ANC)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-hematology-platelet count (PLT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-hematology-platelet count (PLT)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-Concentration of urine protein (UPRO)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-count of urine red blood cells (RBC)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-count of urine white blood cells (WBC)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-Concentration of glucose (GLU-U)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Urinalysis-Concentration of ketones (KET)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of alanine aminotransferase (ALT)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of aspartate aminotransferase (AST)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of γ-glutamyl transferase(γ-GGT)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of alkaline phosphatase (ALP)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2,Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-enzyme activity of cholinesterase (CHE)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of albumin (ALB) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests- Blood biochemistry-Concentration of albumin (ALB)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of total protein (TP)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of total bilirubin (TBil)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of direct bilirubin (DBil)
Time frame: Single-dose: screening, Day-1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of serum creatinine (Cr)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of serum uric acid (UA)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of urea/blood urea nitrogen (Urea/BUN)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of total cholesterol (TC)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of triglycerides (TG)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of high-density lipoprotein cholesterol (HDL-C)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of low-density lipoprotein cholesterol (LDL-C)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of serum glucose (GLU)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of phosphorus ion levels
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of potassium ion levels
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of sodium ion levels
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of chloride ion levels
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Blood biochemistry-Concentration of calcium ion levels
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-prothrombin activity (PTA)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-prothrombin time (PT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-prothrombin time (PT)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-Concentration of fibrinogen (FIB)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-activated partial thromboplastin time (APTT)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Coagulation profile-thrombin time (TT) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Coagulation profile-thrombin time (TT)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests--Concentration of troponinI [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Concentration of troponinI
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests--Concentration of C-reactive protein (CRP) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Concentration of C-reactive protein (CRP)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel-Concentration of immunoglobulin G (IgG)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin A (IgA)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4 [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C4
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG) [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of immunoglobulin G (IgG)
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3 [Safety and Tolerability Evaluation Endpoints]
Clinical laboratory tests-Immunological five-item panel- Concentration of complement C3
Time frame: Single-dose: screening, Day-1, Day3, Day8, Day15, Day22, Day29. Multiple-dose: screening, Day-1, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
abdominal ultrasound- liver-Liver size(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Liver size (millimeter)
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Capsule - The number of participants with hepatic capsule findings normal, abnormal.[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Abdominal examination for hepatic capsule findings (normal / abnormal). The number of participants in each category will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Parenchymal echotexture - The number of participants with hepatic parenchymal echotexture normal, abnormal.[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Parenchymal echotexture. Assessment of hepatic parenchymal echotexture (normal / abnormal). The number of participants in each category will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter).[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Portal Vein Internal Diameter (millimeter)
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-intrahepatic biliary duct dilation-The number of participants with intrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-intrahepatic biliary duct dilation. The number of participants with intrahepatic biliary duct dilation will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-extrahepatic biliary duct dilation-The number of participants with extrahepatic biliary duct dilation .[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-extrahepatic biliary duct dilation.The number of participants with extrahepatic biliary duct dilation will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion-The number of participants with the presence or absence of hepatic solid space-occupying lesions .[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Hepatic Solid Space-Occupying Lesion. Abdominal ultrasound assessment for the presence or absence of hepatic solid space-occupying lesions. The number of participants in each category will be reported. Among participants with identified lesions, lesion size and location will be summarized.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter).( For participants with hepatic solid space-occupying lesions identified on abdominal ultrasound)[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- liver-Size of Hepatic Solid Space-Occupying Lesions (centimeter) . Among participants with hepatic solid space-occupying lesions identified on abdominal ultrasound, lesion size will be recorded in centimeters. Lesion location will also be documented. This field will be blank for participants without hepatic solid space-occupying lesions.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-Gallbladder wall Thickness(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-gallbladder-Gallbladder wall Thickness (millimeter)
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallstones-The number of participants with the presence or absence of gallstones[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-gallbladder-gallstones. Ultrasound assessment for the presence or absence of gallstones. The number of participants in each category will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-gallbladder-gallbladder polyps-The number of participants with the presence or absence of gallbladder polyps. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-gallbladder-gallbladder polyps. Ultrasound assessment for the presence or absence of gallbladder polyps. The number of participants in each category will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-pancreas-Pancreatic Duct Internal Diameter(millimeter).Ultrasound measurement of pancreatic duct internal diameter. Measurements will be recorded and reported in millimeters.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-pancreas-Pancreatic Contour-The number of participants with pancreatic contour normal, abnormal. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-pancreas-Pancreatic Contour. Ultrasound assessment of pancreatic contour (normal / abnormal). The number of participants in each category will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Spleen Longitudinal Diameter (millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- spleen-Spleen Longitudinal Diameter (millimeter). Ultrasound measurement of splenic longitudinal diameter. The measured value will be reported in millimeters.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Spleen Thickness (millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-spleen-Splenic thickness(millimeter). Ultrasound measurement of splenic thickness. The measured value will be reported in millimeters.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-spleen-Splenic Vein Internal Diameter(millimeter)[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-spleen-Splenic Vein Internal Diameter (millimeter). Ultrasound measurement of splenic vein internal diameter. The measured value will be reported in millimeters.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-Ascites Volume-The number of participants with Ascites none, mild, moderate, or large volume[Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound-Ascites Volume-Ultrasound assessment for free intraperitoneal fluid (ascites). Ascites will be categorized as none, mild, moderate, or large volume. The number of participants in each category will be reported.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Renal cortical thickness(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Renal cortical thickness (millimeter). Ultrasound measurement of renal cortical thickness. Measurements will be recorded and reported in millimeters.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys--Renal Pelvic Dilation Diameter(millimeter) [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Renal Pelvic Dilation Diameter (millimeter). Ultrasound measurement of renal pelvic dilation diameter. Measurements will be reported in millimeters.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys--renal cyst -The number of participants with the presence or absence of renal cysts. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-presence or absence of renal cysts. Ultrasound assessment for the presence or absence of renal cysts. The number of participants in each category will be reported. Among participants with renal cysts, cyst size will be measured in millimeters and summarized
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Size of Renal Cyst (millimeter). (For participants with identified renal cysts). [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Size of Renal Cyst (millimeter)For participants with identified renal cysts, cyst size will be recorded in millimeters. This field will be left blank for participants without renal cysts.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Renal Stone -The number of participants with the presence or absence of -Renal Stone. [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Renal Stone.Ultrasound assessment for the presence or absence of renal stones. The number of participants in each category will be reported. Among participants with renal stones, stone size will be measured in millimeters and summarized.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
abdominal ultrasound-both kidneys-Size of Renal Stone (millimeter). (For participants with identified Renal Stone). [Safety and Tolerability Evaluation Endpoints]
abdominal ultrasound- both kidneys-Size of Renal Stone (millimeter).For participants with identified renal stones, stone size will be recorded in millimeters. This field will be left blank for participants without renal stones.
Time frame: For single-dose administration,abdominal ultrasound examinations were performed during the screening phase. For multiple-dose administration, abdominal ultrasound examinations were performed during the screening phase,and then on Day85, Day169, Day337.
FibroScan-Liver stiffness value (LSM, unit: kPa)[Safety and Tolerability Evaluation Endpoints]
FibroScan-Liver stiffness value (LSM, unit: kPa): The specific liver stiffness number and its range, used to assess the degree of liver fibrosis. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients.
Time frame: For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m) [Safety and Tolerability Evaluation Endpoints]
FibroScan-Controlled Attenuation Parameter (CAP, unit: dB/m). The specific CAP data and its range are used to assess the degree of liver fat changes. Results from FibroScan or FibroTouch are acceptable. Study sites not equipped with a FibroScan or FibroTouch transient elastography device may use two-dimensional shear wave elastography (2D-SWE) to measure liver stiffness modulus in patients.
Time frame: For single-dose administration, FibroScan examinations were performed during the screening phase. For multiple-dose administration, FibroScan examinations were performed during the screening phase,and then on Day337.
injection site monitoring-Pain-Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Pain-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pain graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring- Induration-Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring- Induration(2.5-\<5 cm in diameter AND no interference with activities of daily living/5-\<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Induration graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-swelling-Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring--swelling (2.5-\<5 cm in diameter AND no interference with activities of daily living/5-\<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-swelling graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Rash (erythema) -Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Rash (erythema) (2.5-\<5 cm in diameter AND no interference with activities of daily living/5-\<10 cm in diameter OR slight interference with activities of daily living/≥10 cm in diameter, OR ulceration/secondary infection/phlebitis/sterile abscess/drainage from wound, OR marked interference with activities of daily living/Abscess, exfoliative dermatitis, dermal or deep tissue necrosis ). Assessment of injection site monitoring-Rash (erythema) graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Pruritus (at the injection site)-Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Pruritus (at the injection site)-(No/Slight/Marked interference with activities of daily living). Assessment of injection site monitoring-Pruritus (at the injection site) graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
injection site monitoring-Phlegmon -Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported. [Safety and Tolerability Evaluation Endpoints]
injection site monitoring-Phlegmon -(Requires non-parenteral therapy (e.g., oral antibacterial, antifungal, antiviral treatment) OR requires other invasive procedures/Requires intravenous therapy (e.g., intravenous antibacterial, antifungal, antiviral treatment)/ Sepsis, or tissue necrosis, etc.). Assessment of injection site monitoring-Phlegmon graded using CTCAE Version 6.0. The number of participants in each category will be reported.
Time frame: Single-dose: Day1, Day2, Day3, and Day8. Multiple-dose: Day1, Day2, Day3, Day8, Day29, Day36, Day57, Day85, Day113, Day141, Day142, Day143 and Day148.
Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax)
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax)
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t） [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t）
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz)
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F)
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）[Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC_%Extrap) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC\_%Extrap)
Time frame: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax) [Pharmacokinetic Evaluation Parameters]
Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax)
Time frame: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary PD endpoints-quantitative HBsAg [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints-quantitative HBsAg
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints-quantitative HBsAb [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints-quantitative HBsAb
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative anti-Pre-S1 [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative anti-Pre-S1
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg) [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg)
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)[Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb) [Pharmacodynamic (efficacy) Evaluation Indicators]
Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb)
Time frame: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Secondary PD endpoints-HBV DNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Secondary PD endpoints-HBV DNA quantification
Time frame: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-HBV RNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Secondary PD endpoints-HBV RNA quantification
Time frame: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification [Pharmacodynamic (efficacy) Evaluation Indicators]
Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification
Time frame: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Cytokines- Concentration of Interleukin (IL)-1α [Biomarker Evaluation Metrics]
Cytokines- Concentration of Interleukin (IL)- 1α
Time frame: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines-Concentration of Interferon-γ (IFN-γ) [Biomarker Evaluation Metrics]
Cytokines-Concentration of Interferon-γ (IFN-γ)
Time frame: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines-Concentration of Monocyte chemoattractant protein-1 (MCP-1) [Biomarker Evaluation Metrics]
Cytokines-Concentration of Monocyte chemoattractant protein-1 (MCP-1)
Time frame: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines- Concentration of Tumor necrosis factor-α (TNF-α) [Biomarker Evaluation Metrics]
Cytokines-Concentration of Tumor necrosis factor-α (TNF-α)
Time frame: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines-Concentration of IL-15 [Biomarker Evaluation Metrics]
Cytokines-Concentration of IL-15
Time frame: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
T cells- Using ELISpot to detect HBsAg peptide pools in peripheral blood mononuclear cells (PBMCs) [Biomarker Evaluation Metrics]
T cells- Using ELISpot to detect HBsAg peptide pools in peripheral blood mononuclear cells (PBMCs)
Time frame: Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).
T cells- Antigen-specific cells that produce IFN-γ in response to the Pre-S1 peptide library [Biomarker Evaluation Metrics]
T cells- Antigen-specific cells that produce IFN-γ in response to the Pre-S1 peptide library
Time frame: Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).
T cells- the levels of IFN-γ secreted by CD4 T cells and CD8 T cells under stimulation with HBsAg peptide libraries and Pre-S1 peptide libraries were assessed by flow cytometry [Biomarker Evaluation Metrics]
T cells- the levels of IFN-γ secreted by CD4 T cells and CD8 T cells under stimulation with HBsAg peptide libraries and Pre-S1 peptide libraries were assessed by flow cytometry
Time frame: Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).
titer of anti-drug antibody (ADA) [Immunogenicity Evaluation Metric]
titer of anti-drug antibody (ADA)
Time frame: Single-dose: before administration on Day1, Day29. Multiple-dose: before administration on Day1, before administration on Day29, before administration on Day85, and on Day169, Day225, and Day337.
rate of anti-drug antibody (ADA) [Immunogenicity Evaluation Metric]
rate of anti-drug antibody (ADA)
Time frame: Single-dose: before administration on Day1, Day29. Multiple-dose: before administration on Day1, before administration on Day29, before administration on Day85, and on Day169, Day225, and Day337.
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.
Of 73 industry-sponsored phase 1 interventional studies under Hepatitis B, Chronic, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 8 months is below that.
Counting every sponsor, half of 81 studies reached it within 16 months; a quarter within 6 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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