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Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets - Trial NCT04868981

Access comprehensive clinical trial information for NCT04868981 through Pure Global AI's free database. This Phase 1 trial is sponsored by Fujian Cosunter Pharmaceutical Co. Ltd and is currently Completed. The study focuses on Hepatitis B. Target enrollment is 30 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT04868981
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04868981
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Pure Global
DJ Fang

DJ Fang

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Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets
To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic Hepatitis B

Study Focus

Hepatitis B

GST-HG141 tablets

Interventional

drug

Sponsor & Location

Fujian Cosunter Pharmaceutical Co. Ltd

Changchun, China

Timeline & Enrollment

Phase 1

May 31, 2021

Mar 14, 2022

30 participants

Primary Outcome

Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities.,Cmax of GST-HG141,AUC of GST-HG141,t1/2 of GST-HG141,Cl/F of GST-HG141

Summary

To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in
 Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose,
 Multiple-administration Study in Patients With Chronic Hepatitis B (CHB)

ICD-10 Classifications

Acute hepatitis B
Acute hepatitis B without delta-agent and without hepatic coma
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent
Chronic viral hepatitis B without delta-agent : other and unspecified phase

Data Source

ClinicalTrials.gov

NCT04868981

Non-Device Trial