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 range18 Years – 65 Years
SexALL
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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.
✓. 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;
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
Timeframe: Up to 30 days for SAD; up to 113 days for MAD
. 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;
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