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NCT06746311CompletedPhase 1

This is a Phase 1 Study in Which Healthy Volunteers and Participants With Chronic HBV Infection Will be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-101 Injection in Healthy Subjects and Patients With Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Doses, and Dose Escalation Phase 1 Clinical Study

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

Phase 1 Study of HT-101 in Healthy Subjects and Patients With Chronic Hepatitis B The trial consisted of two components. Part A involved a single ascending dose study where healthy participants were administered one dose of HT-101 or placebo subcutaneously (SC). Part B involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered two dose of HT-101 or placebo every 4 weeks subcutaneously (SC).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
82 (actual)
First submitted
9 Dec 2024
Start date
22 Nov 2022
Primary completion date
13 May 2024
Lead sponsor
Suzhou HepaThera Biotech Co., Ltd.
Diseases
Hepatitis B
NCT number
NCT06746311

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 82
  • From 22 Nov 2022 to the primary completion date, 13 May 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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 symptoms or a history of hepatic decompensation;

Lab values

  • 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;

Other

  • Participants with significant liver fibrosis or cirrhosis;
  • Participants with a history or suspected risk of liver cancerr;

Who the study is looking for

  • Part A SAD: Healthy Participant
  • Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
  • Participants who promise having used effective contraception for at least 1 month before screening, and have no plans for pregnancy or donating sperm or eggs, and will voluntarily use effective physical means of contraception (including the partner) during the study and for 3 months after the end of the study;
    • Part B MAD: 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 \> 200 IU/mL and \< 5000 IU/mL; The quantitation level of HBV DNA \< 2×10\^4 IU/mL;
  • 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;

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Friendship Hospital
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BeijingChinaUnknown status
Beijing Ditan Hospital, Capital Medical University
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BeijingChinaUnknown status
The First Bethune Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Nanfang Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Shanghai Public Health Clinical Center
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ShanghaiChinaUnknown status
The affiliated hospital of xuzhou medical university
Coordinator of this site? Confirm its status
XuzhouChinaUnknown status
Yanbian University Hospital
Coordinator of this site? Confirm its status
YanjiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.