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

Recruiting Phase 1 Interventional Study
Hepatitis B Virus Infection
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
GigaGen, Inc. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 sc…
Contacts

Enrikas Vainorius, MD

+1 919-316-6396

giga2339study@grifols.com

CONTACT