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NCT Number: NCT07245953

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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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 ≥ 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

  • 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

HT-101 placebo

Drug

HT-101 placebo given by subcutaneous injection

HT-102 placebo

Drug

HT-102 placebo given by subcutaneous injection

Primary outcomes

  1. Proportion of participants achieving HBsAg < lower limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at W60

    Time frame: From enrollment to the end of treatment at up to 60 weeks

Secondary outcomes

  1. Proportion of participants achieving HBV DNA lower than LLOQ after stopping all anti-HBV treatment

    Time frame: From enrollment to the end of treatment at up to 60 weeks

  2. HBsAg loss rate at W24, W36, W60

    Time frame: From enrollment to the end of treatment at up to 60 weeks

  3. Maximum Change of Serum HBsAg From Baseline Description

    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)

  4. Maximum Change of Serum HBV DNA From Baseline Description

    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)

  5. 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

  6. 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

  7. Maximum Plasma Concentration (Cmax)

    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.

  8. Time to Reach Maximum Plasma Concentration (Tmax)

    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.

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

    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.

  10. Titers of Anti-drug Antibody (ADA) to HT-102 or HT-101

    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 the Efficacy and Safety of HT-101 Injection Combined With HT-102 Injection in Patients With Chronic Hepatitis B

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Nov 24, 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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