NCT05808374

Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	HRS-5635	50mg HRS-5635；100mg HRS-5635；200mg HRS-5635；400mg HRS-5635；600mg HRS-5635；800mg HRS-5635
DRUG	HRS-5635	100mg HRS-5635，Q4W；200mg HRS-5635 ，Q4W；400mg HRS-5635，Q4W；200mg HRS-5635, Q2W
DRUG	HRS-5635	200mg HRS-5635，Q4W
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-04-30
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2023-04-11
• Last updated: 2023-06-18

Locations

1 site across 1 country: China