RecruitingPhase 1NCT07389044

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


Sponsor

IntegerBio

Enrollment

90 participants

Start Date

Feb 20, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IB-001 and a drug called Placebo for people with chronic hepatitis b virus infection. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIB-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.

DRUGPlacebo

Subcutaneous (SC) injection; no active ingredients.


Locations(1)

New Zealand Clinical Research

Auckland, Auckland, New Zealand

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NCT07389044


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