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

Conditions

• Hepatitis B Virus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GIGA-2339 — DRUG
  Administered by intravenous infusion
• Placebo — DRUG
  Administered by intravenous infusion

Study Details

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.

Key Dates

Start date

Nov 13, 2024

Status verified

May 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Single Ascending Dose (SAD)
  Participants will receive a single IV infusion of either GIGA-2339 or placebo in ascending doses on Day 1.
• Experimental: Part 2: Multiple Ascending Dose (MAD)
  Participants will receive multiple IV infusions of either GIGA-2339 or placebo, once every 4 weeks, at a dose determined in Part 1.

Primary Outcome Measure

SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: SAD: Up to Day 105; MAD: Up to Day 245 ]

Central Contacts

• Enrikas Vainorius, MD
  +1 919-316-6396
  [email protected]

Locations (12)

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