HT-101
DrugHT-101 given by subcutaneous injection
NCT Number: NCT07245953
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Beijing Ditan Hospital Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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;
· 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
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
Time frame: From enrollment to the end of treatment at up to 60 weeks
Time frame: From enrollment to the end of treatment at up to 60 weeks
Time frame: From enrollment to the end of treatment at up to 60 weeks
Time frame: Up to 36 weeks
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 Day 1 until 36 weeks (negative values mean reductions from baseline, positive values mean increased from baseline)
Time frame: 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
Time frame: 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
Time frame: HT-101: From predose 1 hour to postdose 8 hours. HT-102: UP to 36 weeks.
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.
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.
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: UP to 36 weeks
ADA analysis for predose 36weeks
Suzhou HepaThera Biotech Co., Ltd.
Industry
A Clinical Study to Evaluate the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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