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NCT05808374Recruiting

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
Fujian Shengdi Pharmaceutical Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
HRS-5635
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Location
Hefei, China
Timeline & enrollment
Phase
Phase 1
Start date
Apr 30, 2023
End date
May 31, 2024
Enrollment
85 participants
Primary outcome

Number of Adverse Events In Part 1,Number of Adverse Events In Part 2

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.

ICD-10 classifications
Acute hepatitis BChronic viral hepatitis B without delta-agentAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agent : other and unspecified phaseChronic viral hepatitis B without delta-agent : immune-tolerant phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05808374
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05808374 through Pure Global AI's free database. This Phase 1 trial is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. and is currently Recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 85 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.