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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for ≥ 6 months, defined as presence of Hepatitis B surface antigen (HBsAg) in serum for ≥ 6 months. * Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening. * Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while participating in the study, or are not received NAs. * Have serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening (for those who are on NAs); or have serum HBV DNA c…
Interventions
- DrugGIGA-2339
Administered by intravenous infusion
- DrugPlacebo
Administered by intravenous infusion
Locations (16)
- Grifols Investigative siteChandler, Arizona
- Grifols Investigative siteHuntington Beach, California
- Grifols Investigative siteLake Forest, California
- Grifols Investigative siteLong Beach, California
- Grifols Investigative siteOakland, California
- Grifols Investigative SitePeachtree Corners, Georgia