A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection

Not Applicable

Active, not recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: HT-101; Drug: HT-102

• Registration Number: NCT07183306
• Lead Sponsor: Suzhou HepaThera Biotech Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Primary Completion: 2026-08-24
• Study Completion: 2027-05-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Cohort A (HT-101)	HT-101	Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks
Experimental: Cohort AA (HT-101)	HT-101	Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks
Experimental: Cohort B （HT-102；HT-101）	HT-101	Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks
Experimental: Cohort B （HT-102；HT-101）	HT-102	Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks
Experimental: Cohort C (HT-101 + HT-102)	HT-101	Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Experimental: Cohort C (HT-101 + HT-102)	HT-102	Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Experimental: Cohort D (HT-101 + HT-102)	HT-101	Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Experimental: Cohort D (HT-101 + HT-102)	HT-102	Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Experimental: Cohort E (HT-101 + HT-102)	HT-101	Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks
Experimental: Cohort E (HT-101 + HT-102)	HT-102	Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	HT-101: From predose 1 hour to postdose 24 hours HT-102：UP to 36 weeks	Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.; Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Time to Reach Maximum Plasma Concentration (Tmax)	HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks	Tmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.; Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC)	HT-101：From predose 1 hour to postdose 24 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 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.; Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Apparent Terminal Elimination Half-life (T1/2)	HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks	T1/2 of HT-101 in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.; Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Apparent Plasma Clearance (CL/F)	HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks	CL/F of HT-101 in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.; Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Apparent volume of distribution（Vd/F）	HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks	Vd/F of HT-101. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.; Changes in the concentration of and HT-102 in serum, From Day1 until 36 weeks
Maximum Change of Serum HBsAg From Baseline	Up to 48 weeks	Maximum change of serum HBsAg from Day 1 until 48 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)
Maximum Change of Serum HBV DNA From Baseline	Up to 48 weeks	Maximum change of serum HBV DNA from Day 1 until 48 weeks (negative values mean reductions from baseline, positive values mean increased from baseline).
Titers of Anti-drug Antibody (ADA) to HT-102	UP to 36 weeks	ADA analysis for predose 36weeks

Trial Locations

Locations (7)

Beijing Ditan Hospital Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China

Xiamen Hospital of Traditional Chinese Medicine; 🇨🇳 Xiamen, Fujian, China

Guangzhou Eighth People's Hospital, Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Qingyuan People's Hospital; 🇨🇳 Qingyuan, Guangdong, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China