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NOT YET RECRUITING
NCT07771777
PHASE1

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

Sponsor: InnovStone Therapeutics Limited

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-08-30

Completion Date

2027-03-30

Last Updated

2026-09-09

Healthy Volunteers

Yes

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