NCT07389044

A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy of Single and Multiple Ascending Doses of IB-001 in Healthy Participants and Participants With Chronic Hepatitis B

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: IntegerBio · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will examine the safety and tolerability of single and multiple doses of IB-001, and will be conducted in two parts: Part A: SAD study in approximately 60 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).

Detailed description

This is a first-in-human, double-blind, randomized, placebo-controlled Phase 1 study of IB-001 administered subcutaneously to evaluate safety, tolerability, PK/PD, and preliminary antiviral activity. The study is comprised of two parts: Part A: Single Ascending Dose (SAD) in Healthy Volunteers Up to 60 healthy adult participants in up to six cohorts (n=10 per cohort; 8 active:2 placebo). Participants will receive a single sub-cutaneous dose of investigational product followed by a 28-day post treatment follow-up. . Part B: Multiple Ascending Dose (MAD) in Treatment-Naïve or Currently-Not-Treated Adults with Chronic Hepatitis B (CHB) Up to 30 adult participants (3 cohorts; n=10 per cohort; 8 active:2 placebo). Once-weekly sub-cutaneous dosing over 4 weeks with 6-week post-treatment follow-up. Dose recommendations in both Part A and Part B will be made by the Safety Review Committee (SRC) based on review of emerging safety data.

Conditions

• Chronic Hepatitis B Virus Infection

Interventions

Type	Name	Description
DRUG	IB-001	Subcutaneous (SC) injectable formulation; single ascending dose in HVs (Part A) and multiple ascending weekly doses for 4 weeks in CHB participants (Part B). Exact dose levels recommended by SRC review.
DRUG	Placebo	Subcutaneous (SC) injection; no active ingredients.

Timeline

• Start date: 2026-02-20
• Primary completion: 2027-04-30
• Completion: 2027-07-01
• First posted: 2026-02-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: New Zealand