A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food of SYH2056 in Healthy Subjects

NCT07771777 | Not Yet Recruiting Phase 1

• 1 other identifier: SYH2056-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (12)

• Adverse events assessments

  Incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs) will be assessed by CTCAE V5.0

  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）

  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）

  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）

  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

  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

  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

  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

  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

  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

  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.

  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.

  Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study

Secondary Outcomes (12)

• Clinician-Administered Dissociative States Scale (CADSS)

  Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study

• Brief Psychiatric Rating Scale (BPRS)

  Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study

• the Physician Withdrawal Checklist 20 (PWC-20)

  Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study

• The Drug Liking Visual Analogue Scale (VAS)

  Up to Day11 for Part1 SAD study, up to Day15 for Part2 FE study

• t1/2

  Day1 to Day4 for Part1 SAD study, Day1 to Day8 for Part2 FE study

Study Arms (9)

Group 1: SYH2056 dose1

EXPERIMENTAL

Drug: SYH2056 tablets, dose1 on Day1 Other: Placebo matching dose1 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 2: SYH2056 dose2

EXPERIMENTAL

Drug: SYH2056 tablets, dose2 on Day1 Other: Placebo matching dose2 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 3: SYH2056 dose3

EXPERIMENTAL

Drug: SYH2056 tablets, dose3 on Day1 Other: Placebo matching dose3 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 4: SYH2056 dose4

EXPERIMENTAL

Drug: SYH2056 tablets, dose4 on Day1 Other: Placebo matching dose4 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 5: SYH2056 dose5

EXPERIMENTAL

Drug: SYH2056 tablets, dose5 on Day1 Other: Placebo matching dose5 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 6: SYH2056 dose6

EXPERIMENTAL

Drug: SYH2056 tablets, dose6 on Day1 Other: Placebo matching dose6 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 7: SYH2056 dose7

EXPERIMENTAL

Drug: SYH2056 tablets, dose7 on Day1 Other: Placebo matching dose7 on Day1

Drug: SYH2056 tablets; Drug: SYH2056 placebo

Group 8: SYH2056 dose8

EXPERIMENTAL

Drug: SYH2056 tablets with or without food, dose8 on Day1 or on Day5

Drug: SYH2056 tablets

Group 9: SYH2056 dose9

EXPERIMENTAL

Drug: SYH2056 tablets with or without food, dose9 on Day1 or on Day5

Drug: SYH2056 tablets

Interventions

SYH2056 tablets DRUG

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

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 placebo DRUG

Placebo Comparator, taken matching the dosage of arm1 to arm7 on day1

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• InnovStone Therapeutics Limited: lead
• Shanghai Mental Health Center: collaborator

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: August 18, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08