This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Approximately 86 patients with chronic hepatitis B infection were planned to be recruited. Among them, Group A and Group AA received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks. Group B received HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks. Groups C, D, and E received HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks. During the study period, all subjects received nucleoside (acid) analogues (NAs) treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Subjects were eligible for inclusion into the study if they met each of the following criteria:
Patient with CHB
Male subjects weighed ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m\^2 (inclusive); Chronic HBV infection for \>/= 6 months; The quantitation level of HBsAg was \> 100 IU/mL and \<3000 IU/mL; The quantitation level of HBV DNA \<LLOQ;
· On Nas therapy for \>/= 6 months at the time of screening
Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;
Exclusion Criteria:
* Subjects were excluded from the study if one or more of the following criteria were applicable
Participants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;
Primary outcome measure(s)
Clinically significant abnormalities — From enrollment to the end of treatment at up to 60 weeks Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Incidence of adverse events (AEs) and serious adverse events (SAEs) — From enrollment to the end of treatment at up to 60 weeks Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Trial sites (7)
Facility
City
Region
Status
Beijing Ditan Hospital Capital Medical University
Beijing
Beijing Municipality
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
Fujian
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou
Guangdong
Nanfang Hospital
Guangzhou
Guangdong
Qingyuan People's Hospital
Qingyuan
Guangdong
Shanghai Public Health Clinical Center
Shanghai
Shanghai Municipality
Sichuan Provincial People's Hospital
Chengdu
Sichuan
More Suzhou HepaThera Biotech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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