NCT06746311

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Suzhou HepaThera Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	HT-101	Single dose of HT-101 administered subcutaneously.
DRUG	HT-101	Multiple dose of HT-101 administered subcutaneously.
DRUG	Placebo	Placebo, containing no active ingredient, administered subcutaneouly

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-05-13
• Completion: 2024-06-17
• First posted: 2024-12-24
• Last updated: 2024-12-24

Locations

7 sites across 1 country: China