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Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG121 Tablets

NCT05576584 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-10-12

No results posted yet for this study

Summary

This phase I clinical study is a phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and food effects of single / continuous administration in Chinese adult healthy subjects

Conditions

  • Pharmacokinetics
  • Food Affect
  • Single Ascending Dose
  • Maximum Applicable Dose

Interventions

DRUG

GST-HG121 tablets

This trial includes single-dose studies and multiple-dose studies, The single-dose study included 5 dose groups of 5 mg, 15 mg, 30 mg, 60 mg, 100 mg（Alternative groups include 150mg and 200mg）. Based on the results of a single dose, select 1 to 3 doses which are tolerated in SAD to conduct multiple dose studies.

DRUG

Placebo

This trial includes single-dose studies and multiple-dose studies, The single-dose study included 5 dose groups of 5 mg, 15 mg, 30 mg, 60 mg, 100 mg（Alternative groups include 150mg and 200mg）. Based on the results of a single dose, select 1 to 3 doses which are tolerated in SAD to conduct multiple dose studies.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Fujian Akeylink Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2023-12-28
Completion
2024-03-30

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 NCT05576584 on ClinicalTrials.gov