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

What this Trial Is About

Researchers are evaluating the safety and tolerability of GIGA-2339, given as single and multiple intravenous doses, in adults with chronic Hepatitis B Virus HBV infection. This Phase 1, randomized, double-blind, placebo-controlled study aims to better understand how the drug behaves in the body and its safety profile in participants with this long-term viral infection. Participants receive either a single intravenous infusion of GIGA-2339 or placebo in ascending doses on Day 1. In the multiple ascending dose part, they receive repeated infusions every 4 weeks at a dose determined from the single dose part. The study has two parts Part 1 assesses single ascending doses and Part 2 evaluates multiple ascending doses of the study drug or placebo. Throughout the study, participants undergo regular safety assessments, including monitoring for any treatment-emergent or serious adverse events up to Day 105 for single doses and Day 245 for multiple doses. Blood samples are collected at various times to measure drug levels and pharmacokinetics. The study lasts several months, with detailed evaluations of how the drug is processed in the body and its potential side effects.

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