A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative… (NCT06115993) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients
China129 participantsStarted 2023-08-03
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept.
Who can participate
Age range
18 Years – 65 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
. The participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening;
. The participants are able to comply with all the protocol requirements;
. The participants (and partners) are willing to take effective contraceptive measures from the screening until at least 6 months after the last dosing;
. Male or female aged 18-55 when signing ICF;
. Body Mass Index (BMI) between 18 to 28 kg/m2 (inclusive) and body weight equal to or over 50 kg for male and 45 kg for female;
. Vital signs and physical examination are normal, or abnormal values are not clinically significant.
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
Number of healthy participants with TEAEs, SAEs
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
2
Number of healthy participants with clinically significant changes in laboratory parameters
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
3
Number of healthy participants with clinically significant changes in vital signs
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
4
Number of healthy participants with clinically significant changes in ECG
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
5
Number of healthy participants with ADA
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
6
The pharmacokinetic profile of AHB-137 in healthy participants: the Cmax of AHB-137
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
7
The pharmacokinetic profile of AHB-137 in healthy participants: Tmax of AHB-137
. The participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening;
. The participants are able to comply with all the protocol requirements;
Exclusion criteria
. Any suspicat screening ion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
. Blood donation or blood loss not less than 400 mL within 12 weeks before screening;
. Drug administration that change the activity of liver enzymes within 28 days prior to screening;
. Receipt of another investigational drug or device within 3 months before first dosing (interventional treatment);
. Clinically significant electrocardiogram (ECG) abnormalities on screening ECG;
. TdP high-risk factors (hypokalemia, hypomagnesemia, decompensated heart failure and acute myocardial infarction), and QTc interval above 450 msec in participants (judged by investigator based on actual screening conditions);
. Pregnant (positive pregnancy test), recently ready to conceive, or lactating female;
. Clinically significant lab examination abnormalities, or other clinically significant diseases discovered within 12 months before screening, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrinological, tumor, pulmonary, immune, mental, or cardiovascular and cerebrovascular diseases;
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
8
The pharmacokinetic profile of AHB-137 in healthy participants: AUC of AHB-137
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
9
The pharmacokinetic profile of AHB-137 in healthy participants: t1/2 of AHB-137
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
10
Number of CHB participants with TEAEs, SAEs
Timeframe: Up to 113 days for Ib
11
Number of CHB participants with clinically significant changes in laboratory parameters
Timeframe: Up to 113 days for Ib
12
Number of CHB participants with clinically significant changes in vital signs
Timeframe: Up to 113 days for Ib
13
Number of CHB participants with clinically significant changes in ECG
Timeframe: Up to 113 days for Ib
14
Proportion of participants achieving HBsAg lower than LLOQ (0.05 IU/mL) and HBV DNA lower than LLOQ at the end of treatment with AHB-137, regardless of whether HBsAg seroconversion is observed