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

NCT07771777 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-08-18

No results posted yet for this study

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

Interventions

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

DRUG

SYH2056 placebo

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

Sponsors & Collaborators

  • Shanghai Mental Health Center

    collaborator OTHER

  • InnovStone Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2027-01-30
Completion
2027-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771777 on ClinicalTrials.gov