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RecruitingNCT07024641

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 Administered as a Single Ascending Dose and Multiple Ascending Doses in Participants With Chronic Hepatitis B Virus Infection

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
GigaGen, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.

Conditions

Interventions

TypeNameDescription
DRUGGIGA-2339Administered by intravenous infusion
DRUGPlaceboAdministered by intravenous infusion

Timeline

Start date
2024-11-13
Primary completion
2027-09-01
Completion
2027-09-01
First posted
2025-06-17
Last updated
2026-03-18

Locations

16 sites across 3 countries: United States, Australia, Hong Kong

Regulatory

Source: ClinicalTrials.gov record NCT07024641. Inclusion in this directory is not an endorsement.

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B V (NCT07024641) · Clinical Trials Directory