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RECRUITING
NCT07024641
PHASE1

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

Sponsor: GigaGen, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-11-13

Completion Date

2027-09

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

GIGA-2339

Administered by intravenous infusion

DRUG

Placebo

Administered by intravenous infusion

Locations (16)

Grifols Investigative site

Chandler, Arizona, United States

Grifols Investigative site

Huntington Beach, California, United States

Grifols Investigative site

Lake Forest, California, United States

Grifols Investigative site

Long Beach, California, United States

Grifols Investigative site

Oakland, California, United States

Grifols Investigative Site

Peachtree Corners, Georgia, United States

Grifols Investigative Site

Iowa City, Iowa, United States

Grifols Investigative Site

Lenexa, Kansas, United States

Grifols Investigative site

Baltimore, Maryland, United States

Grifols Investigative site

San Antonio, Texas, United States

Grifols Investigative site

Webster, Texas, United States

Grifols Investigative site

Richmond, Virginia, United States

Grifols Investigate Site

Concord, New South Wales, Australia

Grifols Investigative site

Fortitude Valley, Queensland, Australia

Grifols Investigative site

Hong Kong, Hong Kong Island, Hong Kong

Grifols Investigative site

Shatin, New Territories, Hong Kong