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

NCT07389044 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-05

No results posted yet for this study

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).

Conditions

  • Chronic Hepatitis B Virus Infection

Interventions

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.

Sponsors & Collaborators

  • IntegerBio

    lead INDUSTRY

Principal Investigators

  • Edward Gane, MBChB, MD, FRACP, MNZ · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2027-04-30
Completion
2027-07-01

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07389044 on ClinicalTrials.gov