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.82 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

HT-101DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (7)

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

Outcomes

Primary Outcomes

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame: From enrollment to the end of treatment at 24 weeks

Clinically significant abnormalities

Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.

Time frame: From enrollment to the end of treatment at 24 weeks

Secondary Outcomes

Maximum Plasma Concentration (Cmax)

Cmax of HT-101 and its metabolite in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours.