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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers - Trial NCT05275465

Access comprehensive clinical trial information for NCT05275465 through Pure Global AI's free database. This Phase 1 trial is sponsored by Huahui Health and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 33 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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NCT05275465
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05275465
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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers
A Randomized, Placebo-controlled, Single-Ascending Dose Phase Ia Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HH-006 in Healthy Volunteers

Study Focus

Hepatitis B

HH-006

Interventional

drug

Sponsor & Location

Huahui Health

Brisbane, Australia

Timeline & Enrollment

Phase 1

Apr 11, 2022

Jan 30, 2023

33 participants

Primary Outcome

Number of participants with treatment emergent adverse events (TEAEs),Severity of treatment emergent adverse events as measured by CTCAE v 5.0,Duration of treatment emergent adverse events

Summary

Huahui Health is developing a treatment for Hepatitis B virus. This study is designed to
 evaluate the safety and tolerability of HH-006, a hepatitis virus neutralizing monoclonal
 antibody in healthy volunteers, and to determine its pharmacokinetic profile and
 immunogenicity.

ICD-10 Classifications

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

Data Source

ClinicalTrials.gov

NCT05275465

Non-Device Trial