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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis B Virus Infection
• Intervention / Treatment: Drug: IB-001; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nick Hourguettes; Phone Number: +1 240 656 2820; Email: ClinOps@integer.bio
• Study Contact Backup: Name: Carey Hwang, MD, PhD; Phone Number: +1 615 491 2553; Email: ClinOps@integer.bio

Study Locations

• New Zealand
  • Auckland
    • Auckland, Auckland, New Zealand, 1010
      • Recruiting
      • New Zealand Clinical Research
      • Contact: Edward Gane, MBChB, MD; Phone Number: 22922 +64 021548371; Email: EdGane@adhb.govt.nz
      • Principal Investigator: Edward Gane, MBChB, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Male or female aged 18 to 70 years.

3. 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.

4. Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.

Exclusion Criteria:

Healthy participants must not meet any of the following criteria at Screening or upon admission to the site (on Day -1).

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.
2. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.
3. 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 on Study Day 1.
4. Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases).
5. 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.
6. Current hepatitis A virus (HAV) infection, hepatitis B virus (HBV) infection , hepatitis C virus (HCV) infection , or hepatitis E virus (HEV) infection .Positive test for HIV-1 or HIV-2 antibodies.
7. Any other active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing.
8. Clinically significant 12-lead ECG abnormalities on Screening ECG.
9. History of cardiac arrhythmias.
10. Physical examination findings at Screening that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
11. Clinically significant abnormal vital signs
12. Laboratory examination abnormalities considered clinically significant by the Investigator at Screening.
13. 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.
14. Any suspicion or history of drug and/or alcohol abuse within the last year.
15. Pregnant, planning to become pregnant during the course of the study, or currently breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: IB-001; Participants receive IB-001, administered subcutaneously according to the assigned cohort schedule. In Part A (SAD), participants receive a single ascending dose. In Part B (MAD), participants receive once-weekly dosing for 4 weeks.	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.
Placebo Comparator: Arm 2: Placebo; Participants receiving placebo subcutaneously, following the same dosing schedule as the active arm (single dose in SAD; once-weekly for 4 weeks in MAD).	Drug: Placebo; Subcutaneous (SC) injection; no active ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and Part B: Number of Patients with Clinically Significant Anti-Drug Antibodies (ADAs).	All immunogenicity data (ADA) are to be analyzed using the Immunogenicity Analysis Population. ADA incidence and titer levels over time will be summarized by dose.	Through Day 29 (Part A), through Day 64 (Part B)
Part B: Changes from Baseline in HBsAg levels over time.	Blood samples will be analyzed for HBsAg levels to establish baseline and determine eligibility; subsequent blood samples will be collected at protocol-specified timepoints to measure HBsAg changes over time.	Through Day 64 (Part B)
Part B: Change from Baseline in Anti-HBs Antibody Titers over time.	Blood samples will be collected at baseline and at protocol-specified timepoints to measure anti-HBs antibody titer changes over time.	Through Day 64
Part B: Reduction from Baseline in HBV DNA levels over time.	Blood samples will be collected at baseline and at protocol-specified timepoints to measure HBV DNA changes over time.	Through Day 64
Part A and Part B: PK Parameter - Maximum Observed Serum Concentration (Cmax) of IB-001	The Cmax is the maximum observed concentration of IB-001 in serum following single or multiple ascending dose administration. Blood samples will be collected at baseline and at protocol-specified timepoints.	Through Day 29 (Part A), through Day 64 (Part B)
Part A and Part B: PK Parameter - Area under the Serum Concentration Time Curve (AUC) of IB-001.	AUC is the area under the concentration time curve of IB-001 in serum following single or multiple ascending dose administration. Blood samples will be collected at baseline and at protocol-specified timepoints.	Through Day 29 (Part A), through Day 64 (Part B)
Part A and Part B: PK Parameter - Time to Observed Maximum Serum Concentration (Tmax) of IB-001.	Tmax is the time it takes to reach maximum concentration of IB-001 in serum following single or multiple ascending dose administration. Blood samples will be collected at baseline and at protocol-specified timepoints.	Through Day 29 (Part A), through Day 64 (Part B)
Part A and Part B: PK Parameter - Terminal Half Life (T1/2) of IB-001.	T1/2 will be measured following single and multiple doses of IB-001. Blood samples will be collected at baseline and at protocol-specified timepoints.	Through Day 29 (Part A), through Day 64 (Part B)

Collaborators and Investigators

• Sponsor: IntegerBio
• Investigators: Principal Investigator: Edward Gane, MBChB, MD, FRACP, MNZ, New Zealand Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HBV; First in Human; Hepatitis B virus; Chronic Hepatitis B; Single Ascending Dose; Multiple Ascending Dose
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: IB001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No