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

Suzhou HepaThera Biotech Co., Ltd.

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: HT-101; Drug: HT-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT07183306

HT-101&HT-102-101

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 6 patient groups

Experimental: Cohort A (HT-101)

Experimental group

Description:

Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks

Treatment:

Drug: HT-101

Experimental: Cohort AA (HT-101)

Experimental group

Description:

Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks

Treatment:

Drug: HT-101

Experimental: Cohort B （HT-102；HT-101）

Experimental group

Description:

Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks

Treatment:

Drug: HT-102

Drug: HT-101

Experimental: Cohort C (HT-101 + HT-102)

Experimental group

Description:

Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks

Treatment:

Drug: HT-102

Drug: HT-101

Experimental: Cohort D (HT-101 + HT-102)

Experimental group

Description:

Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks

Treatment:

Drug: HT-102

Drug: HT-101

Experimental: Cohort E (HT-101 + HT-102)

Experimental group

Description:

Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks

Treatment:

Drug: HT-102

Drug: HT-101