A Phase 1 interventional study of SYH2056 tablets and SYH2056 placebo in Healthy Participants, sponsored by InnovStone Therapeutics Limited. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by InnovStone Therapeutics Limited (part of CSPC Pharmaceutical Group Limited) · Phase 1, Interventional, and Treatment
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK characteristics, and food effect of single ascending oral doses of SYH2056 tablets in healthy participants. The study is planned to have two Parts: Part 1 [the single ascending dose (SAD) study] and Part 2 (the food effect study).
InnovStone Therapeutics Limited is the lead sponsor of 6 studies on the registry; 6 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.
Participants must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria:
A participate will not be eligible for inclusion in this study if any of the following criteria apply:
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.
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.
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.
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.
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
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.
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.
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.
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.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
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.
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.
Drug: SYH2056 tablets, dose1 on Day1 Other: Placebo matching dose1 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets, dose2 on Day1 Other: Placebo matching dose2 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets, dose3 on Day1 Other: Placebo matching dose3 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets, dose4 on Day1 Other: Placebo matching dose4 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets, dose5 on Day1 Other: Placebo matching dose5 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets, dose6 on Day1 Other: Placebo matching dose6 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets, dose7 on Day1 Other: Placebo matching dose7 on Day1
Drug: SYH2056 tablets · Drug: SYH2056 placebo
Drug: SYH2056 tablets with or without food, dose8 on Day1 or on Day5
Drug: SYH2056 tablets
Drug: SYH2056 tablets with or without food, dose9 on Day1 or on Day5
Drug: SYH2056 tablets
SYH2056 tablets, 2mg/tablet or 8mg/tablet, \[WQQ1.1\]taken according to the dosage of arm1 to arm7 on day1 SYH2056 tablets, 8mg/tablet, taken according to the dosage of arm8 and arm9 on day1 or say5
Placebo Comparator, taken matching the dosage of arm1 to arm7 on day1
Adverse events assessments
Incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs) will be assessed by CTCAE V5.0
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in Systolic and Diastolic Blood Pressure Blood Pressure
Changes in systolic and diastolic blood pressure will be assessed during the study（Unit: mmHg）
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in Pulse Rate
Changes in pulse rate will be assessed during the study（Unit: beats/min）
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in Body Temperature
Changes in body temperature will be assessed during the study（Unit: °C）
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Incidence of Clinically Significant Abnormal Findings in Physical Examination
Clinically significant abnormalities identified by physical examination, including general condition, skin and mucous membranes, superficial lymph nodes, head, neck, thyroid, chest (including thorax, lungs, and heart), abdomen, spine/limbs, and nervous system examinations, will be assessed during the study. The results will be presented as the percentage of participants (%) with clinically significant abnormalities
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Clinically Significant Abnormal Findings in Hematology Tests
Clinically significant abnormalities identified by hematology tests, including complete blood count parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalitiesClinically significant abnormalities identified by hematology tests, including complete blood count parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Clinically Significant Abnormal Findings in Blood Biochemistry Tests
Clinically significant abnormalities identified by blood biochemistry tests, including liver function, renal function, and metabolic parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Clinically Significant Abnormal Findings in Coagulation Tests
Clinically significant abnormalities identified by coagulation tests, including coagulation parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Clinically Significant Abnormal Findings in Urinalysis
Clinically significant abnormalities identified by urinalysis, including urine parameters, will be assessed during the study. The results will be presented as the percentage of participants(%) with clinically significant abnormalities
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
12-lead electrocardiograms (ECGs)
Changes in 12-lead electrocardiogram parameters, including heart rate, PR interval, QRS interval, QT interval, and QTc interval, will be assessed
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
Potential effects of SYH2056 on neuropsychiatric status will be assessed by the MOAA/S Score. The MOAA/S score ranges from 0 to 5, with higher scores indicating a higher level of alertness (less sedation) and lower scores indicating a deeper level of sedation.
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Columbia Suicide Severity Rating Scale (C-SSRS) Assessed
Potential effects of SYH2056 on neuropsychiatric status will be assessed by the C-SSRS. Suicidal ideation severity is rated from 0 to 5, with higher scores indicating greater severity of suicidal ideation.
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Clinician-Administered Dissociative States Scale (CADSS)
Hallucinogenic properties of SYH2065 will be assessed by the CADSS. The CADSS total score ranges from 0 to 92, with higher scores indicating greater severity of dissociative symptoms.
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Brief Psychiatric Rating Scale (BPRS)
Hallucinogenic properties of SYH2065 will be assessed by the BPRS. The BPRS total score ranges from 18 to 126, with higher scores indicating greater severity of psychiatric symptoms.
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
the Physician Withdrawal Checklist 20 (PWC-20)
Subject's subjective liking of SYH2065 will be assessed by the PWC-20
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
The Drug Liking Visual Analogue Scale (VAS)
Subject's subjective liking of SYH2065 will be assessed by the VAS. The score ranges from 0 to 100, with higher scores indicating greater subjective liking of the drug.
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
t1/2
Elimination Half-Life of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Tmax
Time to Peak Concentration of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Cmax
Maximum Plasma Concentration of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
AUC0-t
Area under the Drug Concentration-Time Curve from Time 0 to the Last Measurable Time Point of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
AUC0-inf
Area under the Drug Concentration-Time Curve from Time 0 to Infinity of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
CL/F
Apparent Volume of Distribution of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Vz/F
Apparent Volume of Distribution of SYH2056
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
SYH2056 Metabolites
Identification of SYH2056 metabolites in plasma and urine, and to characterize its metabolic pathways
Time frame: Up to Day11 for Part1 SAD study
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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