Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects. (NCT05960240) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
Hong Kong, Italy, Moldova128 participantsStarted 2023-08-30
Plain-language summary
This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.
Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Part 1 and 2 (Healthy Volunteers)
* Male between ages 18-50 years
* Willing and able to provide informed consent
Willing to follow protocol-specified contraception requirement
Inclusion Criteria: Part 3 (CHB Subjects)
* Male or female subjects between the ages of 18-60 years
* Willing to provide informed consent
* Chronic HBV infection for at least 6 months
* Willing to follow protocol-specified contraception requirement
Exclusion Criteria: Part 1 and 2 (Healthy Volunteers)
Key Exclusion Criteria:
* Clinically significant lab abnormalities
* A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
* HIV or Hep C positive
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.
Exclusion Criteria: Part 3 (CHB Subjects)
* Have extensive fibrosis or cirrhosis of the liver
* Have or had liver cancer (hepatocellular carcinoma)
* Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
* Females who breastfeeding, pregnant or who wish to become pregnant during the study
* Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, un…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
Timeframe: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
2
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
Timeframe: [Time Frame: Up to 196 days]
3
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
Timeframe: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
4
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Timeframe: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
5
Part 3: Incidence of clinically significant laboratory abnormalities
Timeframe: [Time Frame: Up to 196 days]
6
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)