This is a Phase 1 Study in Which Healthy Volunteers and Participants with Chronic HBV Infection Will Receive HT-101 or Placebo and Will Be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity

NCT ID: NCT06746311

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2024-06-17

Brief Summary

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).

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A

Single ascending Dose of HT-101 or placebo in Healthy participants subcustaneously.

Group Type: EXPERIMENTAL

HT-101

Intervention Type: DRUG

Single dose of HT-101 administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo, containing no active ingredient, administered subcutaneouly

Part B

Multiple Ascending Dose of HT-101 or placebo in patients with Chronic hepatitis B virus subcustaneously.

Group Type: EXPERIMENTAL

HT-101

Intervention Type: DRUG

Multiple dose of HT-101 administered subcutaneously.

Placebo

Intervention Type: DRUG

Placebo, containing no active ingredient, administered subcutaneouly

Interventions

HT-101

Single dose of HT-101 administered subcutaneously.

Intervention Type: DRUG

HT-101

Multiple dose of HT-101 administered subcutaneously.

Intervention Type: DRUG

Placebo

Placebo, containing no active ingredient, administered subcutaneouly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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;

Exclusion Criteria

• 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 cancerr;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou HepaThera Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Nanfang Hospital

Guangzhou, Guangdong, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Yanbian University Hospital

Yanji, Jilin, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HT-101-101

Identifier Type: -

Identifier Source: org_study_id