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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
Sponsor: GigaGen, Inc.
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
Conditions
Interventions
GIGA-2339
Administered by intravenous infusion
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