Healthy ParticipantsPhase 1NCT07771777
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food of SYH2056 in Healthy Subjects
A Phase 1 study testing SYH2056 tablets in people with Healthy Participants, run by InnovStone Therapeutics Limited.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SYH2056 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be enrolled in this study:
- Age from 18 to 55 years (inclusive).
- Male or female, with the proportion of either sex being no less than 1/3.
- Weight ≥45.0 kg (females) or ≥50.0 kg (males), and body mass index (BMI) within the range of 18.0 to 26.0 kg/m2 (inclusive).
- Results of vital signs, physical examination, 12-lead ECG, laboratory tests, chest X-ray, B-mode ultrasound (liver, gallbladder, spleen, pancreas, kidneys), thyroid function test, etc., are normal or abnormal but not clinically significant as judged by the investigator.
- The participate and their partner agree to use effective non-hormonal contraceptive methods (e.g., condom, inert intrauterine device, female barrier methods [cervical cap or diaphragm with spermicide], vaginal ring, etc.) from signing the ICF until 3 months after the last dose, or have undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). The participate has no plans to donate sperm or eggs from signing the ICF until 3 months after the end of the study.
- Participates must able to read and understand the written informed consent containing study-related information, fully understand the study content, procedures, and possible adverse reactions, voluntarily participate in the clinical study, sign the written ICF, and comply with the study procedures.
Who cannot join
- A participate will not be eligible for inclusion in this study if any of the following criteria apply:
- Participates with history of clinically significant neurological, psychiatric, pulmonary, endocrine, hematological, musculoskeletal, gastrointestinal, cardiovascular, hepatic or renal diseases, or other diseases that might affect the study results or participants' safety as deemed by the investigator or designee.
- Participates with history of neuropsychiatric disorders, including current or past history of mental illness, current or recent use of psychotropic drugs, or other mental or psychological conditions deemed unsuitable for enrollment by the investigator or designee.
- Participates with abnormal blood pressure, such as systolic blood pressure ≥140 mmHg or <90 mmHg; diastolic blood pressure ≥90 mmHg or <60 mmHg.
- Participates with abnormal renal function, such as serum creatinine (Scr) > upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2 or ≥130 mL/min/1.73m2.
- Participates with history of severe drug or food allergies, or judged by the investigator to be potentially allergic to the investigational drug.
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- Participates who have taken any prescription drugs, over-the-counter drugs, herbal medicines, vitamin/dietary supplements, or health products within 4 weeks before signing the ICF. Or those who are using long-acting oral contraceptives, long-acting contraceptive implants, or hormone-releasing intrauterine devices.
- Participates with history of diseases which could affect drug absorption, distribution, metabolism, or excretion (e.g., acute or chronic diarrhea or gastritis, gastrectomy, enterectomy, or cholecystectomy, etc., with the exception of appendectomy).
- Participates who have undergone any surgery within 6 months before signing the ICF, or those who plan to undergo surgery (including cosmetic surgery, dental operation, and oral surgery) during the study.
- Participates with QTcF interval >450 ms (males) or >470 ms (females), or those who have a history of QT interval prolongation.
- Participates who have experienced blood loss or blood donation exceeding 400 mL within 3 months before signing the ICF, or those who have received a blood transfusion or have used blood products.
- Regular alcohol consumption, defined as an average weekly alcohol intake >14 units of alcohol within the 3 months prior to signing the ICF (1 unit = 285 mL of beer, 25 mL of spirits or 150 mL of wine), or positive breath alcohol test, or unable to abstain from alcohol during the study.
- Participates who smoked ≥ 5 cigarettes per day within 6 months before signing the ICF, or who are unable to abstain from any tobacco products during the study.
- Participates with habitual excessive consumption of foods, fruits, or beverages containing purines, caffeine, or grapefruit and grapefruit juice, or other foods that may affect drug absorption, distribution, metabolism, or excretion, within 2 weeks before dosing, such as coffee (>1,100 mL/day), tea (>2,200 mL/day), cola (>2,200 mL/day), energy drinks (>1,100 mL/day) and chocolate (>510 g/day).
- Participates who have enrolled in any clinical studies of drug or medical device within 3 months before signing the ICF.
- Participates with history of drug abuse within 1 year before signing the ICF, or who have a positive drug test as screening.
- Female participates with a positive pregnancy test at screening or who is lactating.
- Participates who have positive results in one or more of the following examinations: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, or anti-Treponema pallidum-specific antibody.
- Participates with history of needle or blood phobia, or those who have difficulty with venous blood collection or can't tolerate venipuncture for other reasons.
- Participates with special dietary requirements and cannot accept the standardized diet and schedule.
- Any other factors that the investigator deems unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of SYH2056 Tablets in Healthy Subjects
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).
- Conditions
- Healthy Participants
- Being tested
- SYH2056 tablets, SYH2056 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2056 tabletsDrug
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
SYH2056 placeboDrug
Placebo Comparator, taken matching the dosage of arm1 to arm7 on day1
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SYH2056 dose1 | Experimental | Drug: SYH2056 tablets, dose1 on Day1 Other: Placebo matching dose1 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 2: SYH2056 dose2 | Experimental | Drug: SYH2056 tablets, dose2 on Day1 Other: Placebo matching dose2 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 3: SYH2056 dose3 | Experimental | Drug: SYH2056 tablets, dose3 on Day1 Other: Placebo matching dose3 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 4: SYH2056 dose4 | Experimental | Drug: SYH2056 tablets, dose4 on Day1 Other: Placebo matching dose4 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 5: SYH2056 dose5 | Experimental | Drug: SYH2056 tablets, dose5 on Day1 Other: Placebo matching dose5 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 6: SYH2056 dose6 | Experimental | Drug: SYH2056 tablets, dose6 on Day1 Other: Placebo matching dose6 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 7: SYH2056 dose7 | Experimental | Drug: SYH2056 tablets, dose7 on Day1 Other: Placebo matching dose7 on Day1 Receives: Drug: SYH2056 tablets; Drug: SYH2056 placebo |
| Group 8: SYH2056 dose8 | Experimental | Drug: SYH2056 tablets with or without food, dose8 on Day1 or on Day5 Receives: Drug: SYH2056 tablets |
| Group 9: SYH2056 dose9 | Experimental | Drug: SYH2056 tablets with or without food, dose9 on Day1 or on Day5 Receives: Drug: SYH2056 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events assessments
Incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs) will be assessed by CTCAE V5.0
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
t1/2
Elimination Half-Life of SYH2056
Measured: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Tmax
Time to Peak Concentration of SYH2056
Measured: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Cmax
Maximum Plasma Concentration of SYH2056
Measured: 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
Measured: 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
Measured: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
CL/F
Apparent Volume of Distribution of SYH2056
Measured: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Vz/F
Apparent Volume of Distribution of SYH2056
Measured: 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
Measured: Up to Day11 for Part1 SAD study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: single ascending dose (SAD) Study randomized, double-blind, placebo-controlled, single ascending dose study Part 2: Food Effect (FE) Study randomized, single-dose, two-period, crossover design
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovStone Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Mental Health Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771777
- Sponsor's protocol ID
- SYH2056-001
- Status last verified
- Aug 2026
- First submitted
- 14 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of SYH2056 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07771777
- Acronym / sponsor ID
- SYH2056-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- InnovStone Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Mental Health Center
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Part 1: single ascending dose (SAD) Study randomized, double-blind, placebo-controlled, single ascending dose study Part 2: Food Effect (FE) Study randomized, single-dose, two-period, crossover design
| Arm | Type | Receives |
|---|---|---|
| Group 1: SYH2056 dose1 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose1 on Day1 Other: Placebo matching dose1 on Day1 |
| Group 2: SYH2056 dose2 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose2 on Day1 Other: Placebo matching dose2 on Day1 |
| Group 3: SYH2056 dose3 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose3 on Day1 Other: Placebo matching dose3 on Day1 |
| Group 4: SYH2056 dose4 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose4 on Day1 Other: Placebo matching dose4 on Day1 |
| Group 5: SYH2056 dose5 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose5 on Day1 Other: Placebo matching dose5 on Day1 |
| Group 6: SYH2056 dose6 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose6 on Day1 Other: Placebo matching dose6 on Day1 |
| Group 7: SYH2056 dose7 | Experimental | Drug: SYH2056 tablets, Drug: SYH2056 placeboDrug: SYH2056 tablets, dose7 on Day1 Other: Placebo matching dose7 on Day1 |
| Group 8: SYH2056 dose8 | Experimental | Drug: SYH2056 tabletsDrug: SYH2056 tablets with or without food, dose8 on Day1 or on Day5 |
| Group 9: SYH2056 dose9 | Experimental | Drug: SYH2056 tabletsDrug: SYH2056 tablets with or without food, dose9 on Day1 or on Day5 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age from 18 to 55 years (inclusive).
- Male or female, with the proportion of either sex being no less than 1/3.
- Weight ≥45.0 kg (females) or ≥50.0 kg (males), and body mass index (BMI) within the range of 18.0 to 26.0 kg/m2 (inclusive).
- Results of vital signs, physical examination, 12-lead ECG, laboratory tests, chest X-ray, B-mode ultrasound (liver, gallbladder, spleen, pancreas, kidneys), thyroid function test, etc., are normal or abnormal but not clinically significant as judged by the investigator.
- The participate and their partner agree to use effective non-hormonal contraceptive methods (e.g., condom, inert intrauterine device, female barrier methods [cervical cap or diaphragm with spermicide], vaginal ring, etc.) from signing the ICF until 3 months after the last dose, or have undergone permanent sterilization (e.g., bilateral tubal ligation, vasectomy, etc.). The participate has no plans to donate sperm or eggs from signing the ICF until 3 months after the end of the study.
Key exclusion criteria (21 listed)
- A participate will not be eligible for inclusion in this study if any of the following criteria apply:
- Participates with history of clinically significant neurological, psychiatric, pulmonary, endocrine, hematological, musculoskeletal, gastrointestinal, cardiovascular, hepatic or renal diseases, or other diseases that might affect the study results or participants' safety as deemed by the investigator or designee.
- Participates with history of neuropsychiatric disorders, including current or past history of mental illness, current or recent use of psychotropic drugs, or other mental or psychological conditions deemed unsuitable for enrollment by the investigator or designee.
- Participates with abnormal blood pressure, such as systolic blood pressure ≥140 mmHg or <90 mmHg; diastolic blood pressure ≥90 mmHg or <60 mmHg.
- Participates with abnormal renal function, such as serum creatinine (Scr) > upper limit of normal (ULN), or estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m2 or ≥130 mL/min/1.73m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYH2056 tabletsSYH2056 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 | Drug | Group 1: SYH2056 dose1, Group 2: SYH2056 dose2, Group 3: SYH2056 dose3, Group 4: SYH2056 dose4, Group 5: SYH2056 dose5, Group 6: SYH2056 dose6, Group 7: SYH2056 dose7, Group 8: SYH2056 dose8, Group 9: SYH2056 dose9 |
| SYH2056 placeboPlacebo Comparator, taken matching the dosage of arm1 to arm7 on day1 | Drug | Group 1: SYH2056 dose1, Group 2: SYH2056 dose2, Group 3: SYH2056 dose3, Group 4: SYH2056 dose4, Group 5: SYH2056 dose5, Group 6: SYH2056 dose6, Group 7: SYH2056 dose7 |
Primary outcome
Adverse events assessments
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs) will be assessed by CTCAE V5.0
Changes in Systolic and Diastolic Blood Pressure Blood Pressure
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in systolic and diastolic blood pressure will be assessed during the study（Unit: mmHg）
Changes in Pulse Rate
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in pulse rate will be assessed during the study（Unit: beats/min）
Changes in Body Temperature
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in body temperature will be assessed during the study（Unit: °C）
Incidence of Clinically Significant Abnormal Findings in Physical Examination
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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
Clinically Significant Abnormal Findings in Hematology Tests
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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
Clinically Significant Abnormal Findings in Blood Biochemistry Tests
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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
Clinically Significant Abnormal Findings in Coagulation Tests
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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
Clinically Significant Abnormal Findings in Urinalysis
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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
12-lead electrocardiograms (ECGs)
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Changes in 12-lead electrocardiogram parameters, including heart rate, PR interval, QRS interval, QT interval, and QTc interval, will be assessed
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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.
Columbia Suicide Severity Rating Scale (C-SSRS) Assessed
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
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.
12 secondary outcomes
Clinician-Administered Dissociative States Scale (CADSS)
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
Brief Psychiatric Rating Scale (BPRS)
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
the Physician Withdrawal Checklist 20 (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)
Time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study
t1/2
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Tmax
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Cmax
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
AUC0-t
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
AUC0-inf
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
CL/F
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
Vz/F
Time frame: Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study
SYH2056 Metabolites
Time frame: Up to Day11 for Part1 SAD study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYH2056 tablets in people with Healthy Participants, run by InnovStone Therapeutics Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events assessments (time frame: Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.