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NCT05763576Recruiting

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Hoffmann-La RochePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Hepatitis B
Drug/Device/Intervention
RO7565020
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Hoffmann-La Roche
Location
Auckland, New Zealand
Timeline & enrollment
Phase
Phase 1
Start date
Apr 28, 2023
End date
Feb 01, 2027
Enrollment
110 participants
Primary outcome

Percentage of Healthy Volunteers With Adverse Events,Percentage of Participants With Chronic Hepatitis B With Adverse Events

Summary

This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I
 clinical study of RO7565020 to investigate the safety and tolerability and to characterize
 the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020
 in healthy participants and/or virologically suppressed participants with chronic hepatitis B
 (CHB).

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
NCT05763576
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05763576 through Pure Global AI's free database. This Phase 1 trial is sponsored by Hoffmann-La Roche and is currently Recruiting. The study focuses on Chronic Hepatitis B. Target enrollment is 110 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.