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

Suzhou HepaThera Biotech Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: HT-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06746311

HT-101-101

Details and patient eligibility

About

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).

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Subjects were eligible for inclusion into the study if they met each of the following 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: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 cancerr;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups

Part A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HT-101

Drug: HT-101

Part B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HT-101

Drug: HT-101