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A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085

NCT07412353 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-02-17

No results posted yet for this study

Summary

Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.

Conditions

  • Healthy Participants

Interventions

DRUG

SYH2085

oral administration

DRUG

Placebo

oral administration

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2026-11-12
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07412353 on ClinicalTrials.gov