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

IntegerBio

Status and phase: Begins enrollment this month; Phase 1

Conditions: Chronic Hepatitis B Virus Infection

Treatments: Drug: IB-001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07389044

IB001-001

Details and patient eligibility

About

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 Volunteer (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Arm 1: IB-001

Experimental group

Description:

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.

Treatment:

Drug: IB-001

Arm 2: Placebo

Placebo Comparator group

Description:

Participants receiving placebo subcutaneously, following the same dosing schedule as the active arm (single dose in SAD; once-weekly for 4 weeks in MAD).

Treatment:

Drug: Placebo