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A Phase I Study of GFH312 in Healthy Chinese Subjects

NCT05991362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-08-23

No results posted yet for this study

Summary

The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.

Conditions

  • Healthy Volunteer

Interventions

DRUG

GFH312 100 mg

Participants receive single dose of GFH312 100 mg orally

DRUG

GFH312 200 mg

Participants receive single dose of GFH312 200 mg orally

DRUG

GFH312 120mg

Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days

OTHER

Placebo

Participants receive placebo matching with GFH312

Sponsors & Collaborators

  • Zhejiang Genfleet Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • LU Yongning, PHD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2023-02-13
Completion
2023-05-30

Countries

  • China

Study Locations

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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 NCT05991362 on ClinicalTrials.gov