A Phase 1 interventional study of xisomab 3G3- Dose 1 and xisomab 3G3-Dose 2 in Thrombosis, sponsored by Aronora, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by Aronora, Inc. · Phase 1, Interventional, and Prevention
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of xisomab 3G3 in healthy adult subjects.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
This study's enrollment of 21 is below the median of 83 across 530 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Aronora, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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.
For a female of non childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to dosing:
A non vasectomized male subject whose sexual partner is sterile or was advised to use one of the following during the course of the study (or prior to study as specified) and for 90 days following dosing:
No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non vasectomized male.
Exclusion Criteria:
History or presence of:
Unable to refrain from or anticipates the use of:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Drug: xisomab 3G3- Dose 1
Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Drug: xisomab 3G3-Dose 2
Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Drug: xisomab 3G3-Dose 3
Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Drug: xisomab 3G3- Dose 4
Participants will receive a single intravenous dose of placebo.
Other: Placebo
Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Also known as: AB023- Dose 1
Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Also known as: AB023- Dose 2
Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Also known as: AB023- Dose 3
Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Also known as: AB023- Dose 4
Participants will receive a single intravenous dose of placebo.
The Number of Subjects With Treatment-related Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Time frame: From Subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
The Number of Subjects With Abnormal Vital Signs That Are Related to Treatment Will be Summarized Using Frequency Counts..
Vital sign measurements (body temperature, respiratory rate, blood pressure, and heart rate)
Time frame: From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts..
12-lead electrocardiogram measurement
Time frame: From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
The Number of Subjects With Abnormal Injection Site Reaction That Are Related to Treatment Will be Summarized Using Frequency Counts..
Injection site reaction (pain, tenderness, erythema/ redness, and induration/ swelling)
Time frame: From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
The Number of Subjects With Abnormal Laboratory Values and/ or Adverse Events That Are Related to Treatment Will be Summarized Using Frequency Counts..
Clinical laboratory tests include serum chemistry, hematology, coagulation parameters (aPTT, PT, and bleeding time), and urinalysis
Time frame: From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts.
Immunogenicity measured by the presence of plasma anti-drug antibodies
Time frame: From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Subject.
Maximum plasma concentration of xisomab 3G3 was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Subject.
The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t), as Calculated by the Linear Trapezoidal Method, After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)\*100. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations). Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
The apparent first order terminal elimination half-life will be calculated as 0.693/Kel. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
The apparent total plasma clearance will be calculated as \[Dose/AUC0-inf\]. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time frame: Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Activated partial thromboplastin time (aPTT) will be used as a surrogate pharmacodynamic marker.
Time frame: Pre-dose (0.5h prior to dose), 1, 24,72, 168, 336, 504, 672h after dosing as well as follow up (7 days after day 29 or after aPTT returned back to baseline)..
| Milestone | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 5 |
| Completed | 4 | 4 | 4 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
| Participants | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| The Number of Subjects With Treatment-related Adverse Events (TEAEs) Will be Summarized Using Frequency Counts. | 1 | 3 | 1 | 2 | 3 |
Vital sign measurements (body temperature, respiratory rate, blood pressure, and heart rate)
| Participants | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| The Number of Subjects With Abnormal Vital Signs That Are Related to Treatment Will be Summarized Using Frequency Counts.. | 0 | 0 | 1 | 0 | 0 |
12-lead electrocardiogram measurement
| Participants | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts.. | 0 | 0 | 0 | 0 | 0 |
Injection site reaction (pain, tenderness, erythema/ redness, and induration/ swelling)
| Participants | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| The Number of Subjects With Abnormal Injection Site Reaction That Are Related to Treatment Will be Summarized Using Frequency Counts.. | 0 | 1 | 0 | 0 | 0 |
Clinical laboratory tests include serum chemistry, hematology, coagulation parameters (aPTT, PT, and bleeding time), and urinalysis
| Participants | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| The Number of Subjects With Abnormal Laboratory Values and/ or Adverse Events That Are Related to Treatment Will be Summarized Using Frequency Counts.. | 0 | 0 | 0 | 0 | 0 |
Immunogenicity measured by the presence of plasma anti-drug antibodies
| Participants | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| Pre-dose (baseline) | 0 | 0 | 0 | 0 | 0 |
| Day 15 | 0 | 0 | 0 | 0 | 0 |
| Day 29 or follow up | 0 | 0 | 0 | 0 | 0 |
Maximum plasma concentration of xisomab 3G3 was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| nanograms/milliliter | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Subject. | 122.7 ± 23.3 | 11210 ± 9.1 | 42510 ± 12.3 | 127200 ± 2.6 |
The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| hours | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Subject. | 0.084 (0.08 to 0.09) | 0.649 (0.26 to 3.02) | 0.088 (0.08 to 0.25) | 0.387 (0.26 to 3.00) |
The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| nanograms*hour/milliliter | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t), as Calculated by the Linear Trapezoidal Method, After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject. | 57.0 ± 46.5 | 361800 ± 21.9 | 5540000 ± 23.9 | 28120000 ± 11.8 |
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| nanogram*hour/milliliter | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject. | 184.7 | 363700 ± 21.8 | 5550000 ± 24.0 | 28140000 ± 11.8 |
The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)\*100. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| percentage of AUC0-inf | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject. | 57.3 | 0.53 ± 0.18 | 0.18 ± 0.07 | 0.07 ± 0.04 |
The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations). Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| 1/hour | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject. | 0.522 | 0.042 ± 0.0042 | 0.011 ± 0.0009 | 0.006 ± 0.0018 |
The apparent first order terminal elimination half-life will be calculated as 0.693/Kel. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| hours | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject. | 1.33 | 16.64 ± 1.56 | 60.63 ± 4.45 | 121.49 ± 40.69 |
The apparent total plasma clearance will be calculated as \[Dose/AUC0-inf\]. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| Liters/hour | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject. | 37.46 | 0.094 ± 0.018 | 0.026 ± 0.003 | 0.014 ± 0.003 |
The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
| Liters | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 |
|---|---|---|---|---|
| The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject. | 69.11 | 2.52 ± 0.59 | 3.72 ± 0.42 | 4.31 ± 0.75 |
Activated partial thromboplastin time (aPTT) will be used as a surrogate pharmacodynamic marker.
| seconds | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| pre-dose | 27.0 ± 1.8 | 26.5 ± 1.3 | 26.3 ± 2.6 | 27.5 ± 1.7 | 29.4 ± 1.7 |
| Day 1, Hour 1 | 32.8 ± 3.8 | 48.3 ± 0.5 | 53.3 ± 5.7 | 57.3 ± 7.8 | 29.4 ± 1.7 |
| Day 2 | 29.0 ± 2.3 | 50.5 ± 5.8 | 52.5 ± 4.8 | 55.8 ± 6.9 | 28.8 ± 2.0 |
| Day 4 | 28.3 ± 2.6 | 48.8 ± 6.5 | 49.8 ± 3.9 | 52.3 ± 5.6 | 27.3 ± 2.1 |
| Day 8 | 27.3 ± 2.1 | 30.5 ± 3.9 | 47.3 ± 2.2 | 49.8 ± 5.3 | 28.6 ± 1.1 |
| Day 15 | 26.8 ± 2.1 | 27.5 ± 2.1 | 47.0 ± 2.9 | 48.0 ± 6.5 | 29.0 ± 1.2 |
| Day 22 | 26.5 ± 2.4 | 27.5 ± 2.6 | 39.5 ± 6.6 | 48.3 ± 6.3 | 28.8 ± 0.8 |
| Day 29 | 27.0 ± 2.3 | 27.5 ± 2.1 | 30.3 ± 2.9 | 47.3 ± 5.0 | 29.2 ± 1.3 |
| Follow Up | 26.8 ± 1.5 | 27.3 ± 1.7 | 28.3 ± 1.5 | 28.0 ± 2.2 | 29.2 ± 1.3 |
Collected over Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xisomab 3G3- Dose 1 | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Xisomab 3G3- Dose 2 | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Xisomab 3G3- Dose 3 | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Xisomab 3G3- Dose 4 | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Placebo | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Event | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo |
|---|---|---|---|---|---|
| Ear painEar and labyrinth disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Middle ear effusionEar and labyrinth disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| ToothacheGastrointestinal disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Injection site ecchymosisGeneral disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Injection site painGeneral disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Upper respiritory tract infectionInfections and infestations | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Blood pressure diastolic increasedInvestigations | 0/4 | 0/4 | 1/4 | 0/4 | 0/5 |
| HeadacheNervous system disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Oralpharangeal painRespiratory, thoracic and mediastinal disorders | 0/4 | 1/4 | 0/4 | 0/4 | 0/5 |
| Productive coughRespiratory, thoracic and mediastinal disorders | 0/4 | 1/4 | 0/4 | 1/4 | 0/5 |
| Age, Continuous(years) | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 42.3 (37 to 47) | 33.0 (25 to 46) | 32.0 (22 to 42) | 42.0 (40 to 45) | 32.2 (25 to 42) | 36.1 (22 to 47) |
| Sex: Female, Male(Participants) | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 2 | 1 | 1 | 2 | 9 |
| Male | 1 | 2 | 3 | 3 | 3 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 3 | 3 | 4 | 17 |
| Not Hispanic or Latino | 0 | 1 | 1 | 1 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 0 | 1 |
| White | 4 | 3 | 4 | 3 | 5 | 19 |
| More than one race | 0 | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Xisomab 3G3- Dose 1 | Xisomab 3G3- Dose 2 | Xisomab 3G3- Dose 3 | Xisomab 3G3- Dose 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| United States | 4 | 4 | 4 | 4 | 5 | 21 |
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Studies of the drug tested here: AB023
Aronora, Inc.