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Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets

NCT04499443 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-09-24

No results posted yet for this study

Summary

To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

Conditions

Interventions

DRUG

GST-HG131 tablets

This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.

DRUG

Placebo

This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.

Sponsors & Collaborators

  • Fujian Cosunter Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Junqi Niu, PHD · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-03-31
Completion
2021-05-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04499443 on ClinicalTrials.gov