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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 - Trial NCT05808374

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.

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NCT05808374
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05808374
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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

Study Focus

Chronic Hepatitis B

HRS-5635

Interventional

drug

Sponsor & Location

Fujian Shengdi Pharmaceutical Co., Ltd.

Hefei, China

Timeline & Enrollment

Phase 1

Apr 30, 2023

May 31, 2024

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

Data Source

ClinicalTrials.gov

NCT05808374

Non-Device Trial