drugset / Trial / 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

NCT06746311 ↗

Phase 1 Completed 82 enrolled Suzhou HepaThera Biotech Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2022-11-22
Primary completion
2024-05-13
Completion
2024-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject HT-101 Unknown — Subcutaneous