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Phase I Study of GST-HG151 Tablets in Healthy Volunteers

NCT05345964 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2022-04-26

No results posted yet for this study

Summary

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Impact of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers

Conditions

  • Healthy Volunteers

Interventions

DRUG

GST-HG151

Subjects will take GST-HG151 orally(once daily) on Day 1

DRUG

Placebo

Subjects will take Placebo orally(once daily) on Day 1

DRUG

GST-HG151

Subjects will take GST-HG151 orally (once daily) from Day 1 to Day 7

DRUG

Placebo

Subjects will take Placebo orally (once daily) from day 1 to day 7

DRUG

GST-HG151

Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 \~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days.

DRUG

GST-HG151

Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 \~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days.

Sponsors & Collaborators

  • Fujian Cosunter Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Ling Zheng, Bachelor · Mengchao Hepatpbiliary Hospital of Fujian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2023-03-31
Completion
2023-05-31

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 NCT05345964 on ClinicalTrials.gov