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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
Sponsor: Suzhou HepaThera Biotech Co., Ltd.
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2022-11-22
Completion Date
2024-06-17
Last Updated
2026-11-02
Healthy Volunteers
Yes
Conditions
Interventions
HT-101
Single dose of HT-101 administered subcutaneously.
HT-101
Multiple dose of HT-101 administered subcutaneously.
Placebo
Placebo, containing no active ingredient, administered subcutaneouly
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