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NCT Number: NCT07183306

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Ditan Hospital Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

HT-101

Drug

HT-101 given by subcutaneous injection.

HT-102

Drug

HT-102 given by subcutaneous injection.

Primary outcomes

  1. Clinically significant abnormalities

    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.

  2. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    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.

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 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

  2. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: 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

  3. Area Under the Plasma Concentration Versus Time Curve (AUC)

    Time frame: 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

  4. Apparent Terminal Elimination Half-life (T1/2)

    Time frame: 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

  5. Apparent Plasma Clearance (CL/F)

    Time frame: 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

  6. Apparent volume of distribution（Vd/F）

    Time frame: 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

  7. Maximum Change of Serum HBsAg From Baseline

    Time frame: 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)

  8. Maximum Change of Serum HBV DNA From Baseline

    Time frame: 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).

  9. Titers of Anti-drug Antibody (ADA) to HT-102

    Time frame: UP to 36 weeks

    ADA analysis for predose 36weeks

Sponsors and collaborators

Lead sponsor

Suzhou HepaThera Biotech Co., Ltd.

Industry

Registry information

Official study title

A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-101 Injection and/or HT-102 Injection in Patients With Chronic Hepatitis B Virus Infection

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

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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