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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Chronic Hepatitis B Virus Infection

In brief

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).

Key facts

Study ID

NCT07389044

Run by

IntegerBio

People needed

80

Starts

2026-02-20

Expected to finish

2027-07-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.
• Pregnant or planning to become pregnant during the course of the study, or currently breastfeeding.
• Use of more than 5 cigarettes, or equivalent, a day in the 3 months prior to Screening. Is unwilling to abstain from nicotine-containing products for 48 hours prior to admission to the site and during the in-house stay at the clinical research unit.
• Receipt of any investigational drug or product within 90 days of Study Day 1 or within 5 times the elimination half-life of the medication prior to first dosing with the IP, whichever is earlier. Receipt of an invasive medical device within 90 days before first dosing with the IP that in the opinion of the PI or designee may impact the ability of the participant to complete all protocol-required procedures. Participants must not have participated in interventional clinical studies more than 4 times per year.
• Use of any prescribed or over-the-counter medications (including vitamins, supplements, or herbal remedies) within 2 weeks of first dosing with the IP or within 5 times the elimination half-life of the medication prior to first dosing with the IP (whichever is longer). Note: Simple analgesia (paracetamol < 2 g/day, nonsteroidal anti-inflammatory drug [NSAID] at therapeutic doses) may be permitted at the discretion of the PI, and may only be used as premedication prior to dosing of IP if recommended by the SRC.
• Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP on Study Day 1. Note: COVID-19 vaccines are not considered live vaccines.
• Any suspicion or history of drug and/or alcohol abuse within the last year.
• Positive toxicology Screening panel (urine test including qualitative identification of tetrahydrocannabinol, cocaine, amphetamines, benzodiazepines, opiates, methadone, methamphetamines, ecstasy, and phencyclidine).
• Positive alcohol breath test at Screening and/or on Study Day -1.
• History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before dosing with the IP on Study Day 1, and during the in-house stay at the clinical research unit.
• Uses more than 5 cigarettes, or equivalent, per day in the 3 months prior to Screening, and/or is unwilling to abstain from nicotine-containing products for 48 hours prior to admission to the site and during the in-house stay at the clinical research unit.

Where it is running

• Arensia Exploratory Medicine Chisinau — Chisinau, Moldova (enrolling)
• New Zealand Clinical Research — Auckland, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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