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New treatment option for Chronic Hepatitis B Virus Infection
Official title A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07389044
What this study is testing
What is IB-001?
IB-001 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for chronic hepatitis b virus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- PART A: Healthy Volunteers
- 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...
- Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.
You likely can't join 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...
- 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...
- Any underlying medical condition (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological...
- History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening or cervical intraepithelial neoplasia that...
See the full eligibility criteria
Who can join
- PART A: Healthy Volunteers
- 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...
- Non-tattooed, clear injection site suitable for SC injection and monitoring in the opinion of the Investigator.
What rules you out
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Pregnant (positive serum pregnancy test at Screening or a positive urine pregnancy test predose on Study Day -1), planning to become pregnant during the course of the study, or currently breastfeeding.
- Any other factor that makes it inappropriate for study participation per the Investigator's judgment. PART B: Participants with Chronic Hepatitis B (CHB) Inclusion Criteria:
- Able and willing to provide written informed consent.
- Male or female aged 18 to 70 years,
- BMI between 18 and 35 kg/m2.
- 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...
- Diagnosed with CHB and are HBeAg-negative (on 2 occasions at least 6 months apart) and have HBsAg titers of ≥ 100 IU/mL at Screening.
- Participants must be treatment naive (i.e., have never received treatment with HBV antiviral medicines [NUCs, IFN] or an investigational anti-HBV agent) or currently not treated (i.e., not been on treatment with...
- Vital signs and physical examination are normal, or abnormal values are not clinically significant in the opinion of the Investigator. Exclusion Criteria:
- Evidence or history of liver disease of non-HBV etiology, including but not limited to HAV, HCV, HDV, or HEV (endemic regions only) infections; drug- or alcohol-related liver disease; autoimmune hepatitis...
- Diagnosed or suspected hepatocellular carcinoma (HCC).
- Significant liver fibrosis or cirrhosis (FibroScan result \> 8.5 kPa within 12 months of Screening; Prior liver biopsy with Metavir F3 fibrosis or F4 cirrhosis within 2 years of Screening; AST-to-Platelet Index (APRI)...
- Positive for HIV-1 or HIV-2 at Screening.
- Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 2 weeks of first dosing of investigational product (IP).
- Any of the following clinical laboratory values at Screening: ALT or AST ≥ 3 × ULN; blood platelet counts \ 1.2 × ULN.
- History of severe allergic or anaphylactic reactions, or sensitivity to the IP or 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 first dosing with the IP.
- History or presence of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity...
- History or presence of significant (as judged by the Investigator) cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological disorders, or diagnosed central or peripheral neurological disease...
- Clinically significant 12-lead ECG abnormalities on Screening ECG or history of cardiac arrhythmias, risk factors for Torsade de Pointes (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial...
- Physical examination findings that are considered clinically significant by the Investigator and likely to adversely impact study conduct and/or interpretation.
- Clinically significant abnormal vital signs, confirmed with retesting after at least 5 minutes of additional rest.
- History (within 90 days of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
- Positive alcohol breath test at Screening and/or on Study Day 1. Alcohol consumption will be prohibited at least 48 hours before each dose with the IP, and during any in-house stays in the clinical research unit or...
- Use of more than 5 cigarettes per day or equivalent (e.g., cigarettes, vapes, nicotine patches, cigars, chewing tobacco) in the 3 months prior to Screening. Nicotine-containing products (eg, cigars, cigarettes, vapes)...
- Participants must not have participated in treatment clinical studies more than 4 times per year. Receipt of any investigational drug or product within 90-days of Study Day 1 or within 5 times the elimination half-life...
- Received solid organ or bone marrow transplant.
- Any immunosuppressing, immunomodulator (e.g., thymosin) or cytotoxic drug administrations within 6 months before first dosing with the IP (Day 1).
- Received any antiplatelet (e.g., aspirin, clopidogrel) or antithrombotic therapy (e.g., warfarin, dabigatran, apixaban) within 14 days prior to first dosing with the IP and throughout the study.
- Has received live vaccine(s) within 28 days of Screening or plans to receive live vaccines within 28 days of dosing with the IP. Note: COVID-19 vaccines are not considered live vaccines.
- Use of corticosteroids above 5 mg/day of prednisone (or equivalent) or other immunosuppressive medications within 4 weeks prior to Screening. Note: topical, intra-articular and inhaled steroids allowed.
- Use of any herbal medicines or supplements within 3 months prior to Screening visit that are known to be hepatotoxic based on Investigator's opinion or who have initiated any new herbal medicine or supplement within 30...
- Pregnant (positive serum pregnancy test at Screening or a positive urine pregnancy test predose on Study Day 1), planning to become pregnant during the course of the study, or currently breastfeeding.
- Any other factor that makes it inappropriate for study participation per the Investigator's judgment. Other prohibited medications during the study: Treatments that may increase ALT or AST (eg, augmentin, \> 2 g...
The study team makes the final eligibility decision.
Where it's taking place
- Chisinau, Moldova
- Auckland, Auckland, New Zealand
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chisinau, Moldova; Auckland, Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.