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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shanghai Public Health Clinical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Yanbian University Hospital Coordinator of this site? Confirm its status | Yanji | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.