Actively Recruiting
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
Led by IntegerBio · Updated on 2026-03-05
90
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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 Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).
CONDITIONS
Official Title
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent.
- Male or female aged 18 to 70 years.
- Females must not be of childbearing potential OR if of childbearing potential, must be non-pregnant, non-lactating, and willing to use effective contraception.
- Males with partners of childbearing potential must be surgically sterile or willing to use effective contraception.
- Non-tattooed, clear injection site suitable for subcutaneous injection and monitoring as judged by the Investigator.
You will not qualify if you...
- Major surgery requiring general anesthesia within 12 weeks prior to screening or expected during the study.
- History of severe allergic or anaphylactic reactions or sensitivity to the investigational product or its ingredients.
- Blood donation or blood loss of 1 unit (450 mL) or more within 4 weeks before screening or plasma donations within 7 days prior to dosing.
- Any significant underlying medical condition including gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, cardiovascular, or cerebrovascular diseases.
- History of malignancy except non-melanoma skin cancer excised more than 1 year prior or cured cervical intraepithelial neoplasia over 5 years prior.
- Current infection with hepatitis A, B, C, or E viruses, or positive test for HIV-1 or HIV-2.
- Any other active infection requiring systemic antiviral or antimicrobial therapy not completed within 2 weeks of dosing.
- Clinically significant abnormalities in ECG, cardiac arrhythmias, vital signs, or physical exam judged significant by the Investigator.
- Clinically significant abnormal lab results at screening.
- Use of prescribed or over-the-counter medications within 2 weeks of dosing or within 5 times their elimination half-life.
- History or suspicion of drug or alcohol abuse within the last year.
- Pregnant, planning pregnancy, or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research
Auckland, Auckland, New Zealand, 1010
Actively Recruiting
Research Team
C
Carey Hwang, MD, PhD
CONTACT
N
Nick Hourguettes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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