A Phase 2 interventional study of HT-101 and HT-102 in Chronic Hepatitis B, sponsored by Suzhou HepaThera Biotech Co., Ltd.. Active, not recruiting at 12 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Suzhou HepaThera Biotech Co., Ltd. · Phase 2, Interventional, and Treatment
This study is A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HT-101 injection combined with HT-102 injection in patients with chronic hepatitis B. It consists of two phases: the main trial and the extension period. The main trial phase aims to explore the efficacy of different courses of HT-101 injection combined with HT-102 injection in treating patients with chronic hepatitis B and evaluate the optimal treatment strategy. The extension period phase, based on the main trial, assesses the long-term safety and efficacy of HT-101 injection combined with HT-102 injection.
942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 683 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Suzhou HepaThera Biotech Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with CHB Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 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;
Exclusion Criteria:
Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Drug: HT-101 · Drug: HT-102
Participants will receive Placebo injection, administered Q4W for 8 weeks and sequential dosed with HT-101 injection combined with HT-102 injection, administered once every 4 weeks for another 16 weeks
Drug: HT-101 · Drug: HT-102 · Drug: HT-101 placebo · Drug: HT-102 placebo
HT-101 given by subcutaneous injection
HT-102 given by subcutaneous injection
HT-101 placebo given by subcutaneous injection
HT-102 placebo given by subcutaneous injection
Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60
Time frame: From enrollment to the end of treatment at up to 60 weeks
Proportion of participants achieving HBV DNA lower than LLOQ after stopping all anti-HBV treatment
Time frame: From enrollment to the end of treatment at up to 60 weeks
HBsAg loss rate at W24, W36, W60
Time frame: From enrollment to the end of treatment at up to 60 weeks
Maximum Change of Serum HBsAg From Baseline Description
Maximum change of serum HBsAg from Day 1 until 36 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)
Time frame: Up to 36 weeks
Maximum Change of Serum HBV DNA From Baseline Description
Maximum change of serum HBV DNA from Day 1 until 36 weeks (negative values mean reductions from baseline, positive values mean increased from baseline)
Time frame: Up to 36 weeks.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From enrollment to the end of treatment at up to 60 weeks
Clinically significant abnormalities
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0
Time frame: From enrollment to the end of treatment at up to 60 weeks
Maximum Plasma Concentration (Cmax)
Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.
Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.
Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
Area Under the Plasma Concentration Versus Time Curve (AUC)
AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration: Predose 1 hour; Postdose 2 hours, 4 hours, 6 hours, 8 hours. Changes in the concentration of HT-102 in serum, From Day1 until 36 weeks.
Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101
ADA analysis for predose 36weeks
Time frame: UP to 36 weeks
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Suzhou HepaThera Biotech Co., Ltd.