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

NCT07389044 | Recruiting Phase 1

• 1 other identifier: IB001-001
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Chronic Hepatitis B Virus Infection

Keywords

First in Human; Hepatitis B virus; HBV; Chronic Hepatitis B; Dose finding; Dose Ranging

Outcome Measures

Primary Outcomes (6)

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

  Treatment-Emergent Adverse Events (TEAEs) are adverse events that first appear or worsen in severity during the course of the clinical study, regardless of whether they are related to the investigational product (IP) or not. TEAEs will be coded using MedDRA and summarized by SOC, PT, severity, and relationship to IP. Treatment-related AEs (possibly/probably/definitely related) will also be summarized separately. A by-participant AE listing will be provided

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

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

  An AE is any unfavorable medical occurrence in a study participant administered an investigational product. The AE does not necessarily have a causal relationship with the treatment. All AEs will be graded for severity according to NCI-CTCAE classification. If an appropriate AE term is not found in NCI-CTCAE, the AE will be graded as follows: Grade 1 (mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Severe) and Grade 5 (Death).

  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)

  AEs of special interest include Cytokine Release Syndrome (CRS), Injection Site Reactions (ISRs) and Unexplained Liver Biochemistry Elevations. Reported AESIs will be graded according to NCI-CTCAE classification. If an appropriate AE term is not found in NCI-CTCAE, the AESI will be graded as follows: Grade 1 (mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (Severe) and Grade 5 (Death).

  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

  Assessment Method - Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, and coagulation) will be reported.

  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.

  Number of participants with vital signs abnormalities will be reported. Vital signs include body temperature, pulse rate, respiratory rate, and blood pressure.

  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.

  Number of participants with electrocardiogram (ECG) abnormalities will be reported.

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

Secondary Outcomes (8)

• Part A and Part B: Number of Patients with Clinically Significant Anti-Drug Antibodies (ADAs).

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

• Part B: Changes from Baseline in HBsAg levels over time.

  Through Day 64 (Part B)

• Part B: Change from Baseline in Anti-HBs Antibody Titers over time.

  Through Day 64

• Part B: Reduction from Baseline in HBV DNA levels over time.

  Through Day 64

• Part A and Part B: PK Parameter - Maximum Observed Serum Concentration (Cmax) of IB-001

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

Study Arms (2)

Arm 1: IB-001

EXPERIMENTAL

Participants receive IB-001, administered subcutaneously according to the assigned cohort schedule. In Part A, participants receive a single dose. In Part B, participants receive once-weekly dosing for 4 weeks.

Drug: IB-001

Arm 2: Placebo

PLACEBO COMPARATOR

Participants receiving placebo, follow the same dosing schedule as the active arm (single dose in Part A; once-weekly for 4 weeks in Part B).

Other: Placebo

Interventions

IB-001 DRUG

IB-001 is an investigational product targeting the type I IFN (IFN-I) signaling pathway. Subcutaneous (SC) injectable formulation; single doses in HVs (Part A) and weekly doses for 4 weeks in CHB participants (Part B). Exact dose levels recommended by SRC.

Arm 1: IB-001

Placebo OTHER

Sodium Chloride (NaCl) 0.9 % administered subcutaneously as a single dose (Part A) and weekly dose for 4 weeks (Part B).

Arm 2: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Healthy Volunteer participants must not meet any of the following criteria at Screening or upon admission to the site (on Day -1).
• 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.
• History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
• Blood donation or blood loss of ≥ 1 unit (450 mL) of whole blood within 4 weeks before Screening or plasma donations within 7 days prior to dosing of investigational product (IP).
• Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases).
• History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening or cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
• Current hepatitis A virus (HAV) infection, hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection.
• Positive test for HIV-1 or HIV-2 antibodies.
• Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.
• Clinically significant abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and a QTcF \> 450 ms (males) or QTcF \> 470 ms (females) at Screening.
• Physical examination findings at Screening that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
• Clinically significant abnormal vital signs
• Laboratory abnormalities considered clinically significant by the Investigator at Screening. From Cohort A3 onwards, participants with blood platelet counts \< 150 × 109/L or absolute neutrophil counts \< 1.5 × 109/L will be excluded.
• Use of any prescribed or over-the-counter medications (including vitamins or herbal remedies) within 2 weeks of first dosing or within 5 times the elimination half-life of the medication prior to first dosing.
• Any suspicion or history of drug and/or alcohol abuse within the last year.

Sponsors & Collaborators

• IntegerBio: lead

Study Sites (2)

Arensia Exploratory Medicine Chisinau

Chisinau, 2025, Moldova

RECRUITING

New Zealand Clinical Research

Auckland, 1010, New Zealand

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Gane, MBChB, MD, FRACP, MNZ

  New Zealand Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carey Hwang, MD, PhD

CONTACT

+1 615 491 2553; ClinOps@integer.bio

Nick Hourguettes

CONTACT

+1 240 656 2820; ClinOps@integer.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 5, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); MO (1)