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

NCT07183306 | Active Not Recruiting Phase 1

• 1 other identifier: HT-101&HT-102-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Clinically significant abnormalities

  Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

  From enrollment to the end of treatment at up to 60 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.

  From enrollment to the end of treatment at up to 60 weeks

Secondary Outcomes (9)

• Maximum Plasma Concentration (Cmax)

  HT-101: From predose 1 hour to postdose 24 hours HT-102：UP to 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

• 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

• Apparent Terminal Elimination Half-life (T1/2)

  HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks

• Apparent Plasma Clearance (CL/F)

  HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks

Study Arms (6)

Experimental: Cohort A (HT-101)

EXPERIMENTAL

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

Drug: HT-101

Experimental: Cohort AA (HT-101)

EXPERIMENTAL

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

Drug: HT-101

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

EXPERIMENTAL

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

Drug: HT-101; Drug: HT-102

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

EXPERIMENTAL

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

Drug: HT-101; Drug: HT-102

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

EXPERIMENTAL

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

Drug: HT-101; Drug: HT-102

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

EXPERIMENTAL

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

Drug: HT-101; Drug: HT-102

Interventions

HT-101 DRUG

HT-101 given by subcutaneous injection.

Experimental: Cohort A (HT-101); Experimental: Cohort AA (HT-101); Experimental: Cohort B （HT-102；HT-101）; Experimental: Cohort C (HT-101 + HT-102); Experimental: Cohort D (HT-101 + HT-102); Experimental: Cohort E (HT-101 + HT-102)

HT-102 DRUG

HT-102 given by subcutaneous injection.

Experimental: Cohort B （HT-102；HT-101）; Experimental: Cohort C (HT-101 + HT-102); Experimental: Cohort D (HT-101 + HT-102); Experimental: Cohort E (HT-101 + HT-102)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou HepaThera Biotech Co., Ltd.: lead

Study Sites (7)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, 361001, China

Location

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510440, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 19, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): May 3, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (7)