NCT04868981

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This study includes 3 cohorts of 25 mg BID, 50 mg BID and 100 mg BID. 30 patients with chronic hepatitis B will be enrolled in this study and each cohort will enroll 10 patients (GST-HG141 tablets : PBO=8:2). All enrolled patients will be given research drugs twice a day for 28 days (D28 was administered only once in the morning). And each cohort requires at least 4 subjects with elevated ALT. Tolerability, pharmacodynamics and pharmacokinetics will be evaluated according to the protocol.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	GST-HG141 tablets	Administrate GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses
DRUG	Matching Placebos for GST-HG141 tablets	Administrate the placebos for GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses

Timeline

• Start date: 2021-05-31
• Primary completion: 2022-02-23
• Completion: 2022-03-14
• First posted: 2021-05-03
• Last updated: 2022-06-07

Locations

1 site across 1 country: China