RecruitingPhase 1

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

Moldova, New Zealand80 participantsStarted 2026-02-20

Plain-language 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 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able and willing to provide written informed consent.
. Male or female aged 18 to 70 years.
. Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception. Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.
. Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.

Exclusion criteria

. Major surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A and Part B: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs).

Timeframe: Through Day 29 (Part A), through Day 64 (Part B).

Part A and Part B: Number of Participants with Adverse Events (AEs) by Severity

Timeframe: Through Day 29 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Participants with Adverse Events (AEs) of Special Interest (AESIs)

Timeframe: Through Day 29 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Timeframe: Through Day 15 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Participants with Clinically Significant Changes in Vital Signs.

Timeframe: Through Day 15 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Patients with Clinically Significant Changes in Cardiac Parameters.

Timeframe: Through Day 15 (Part A), through Day 64 (Part B)

Trial details

NCT IDNCT07389044

SponsorIntegerBio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Carey Hwang, MD, PhD

+1 615 491 2553 ClinOps@integer.bio

View on ClinicalTrials.gov More Chronic Hepatitis B Virus Infection trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Able and willing to provide written informed consent.
. Male or female aged 18 to 70 years.
. Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use a highly effective method of contraception. Males whose partners are of childbearing potential must either be surgically sterile or willing to use a highly effective acceptable method of contraception.
. Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.

Exclusion criteria

. Major surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.

What they're measuring

Part A and Part B: Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs).

Timeframe: Through Day 29 (Part A), through Day 64 (Part B).

Part A and Part B: Number of Participants with Adverse Events (AEs) by Severity

Timeframe: Through Day 29 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Participants with Adverse Events (AEs) of Special Interest (AESIs)

Timeframe: Through Day 29 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Timeframe: Through Day 15 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Participants with Clinically Significant Changes in Vital Signs.

Timeframe: Through Day 15 (Part A), through Day 64 (Part B)

Part A and Part B: Number of Patients with Clinically Significant Changes in Cardiac Parameters.

Timeframe: Through Day 15 (Part A), through Day 64 (Part B)