drugset
drugset / Trial / NCT04847440

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection

NCT04847440 ↗

Phase 2 Terminated 40 enrolled Antios Therapeutics, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in both volunteers with chronic hepatitis B virus infection and in volunteers with hepatitis D virus coinfection. Volunteers will be administered multiple oral doses of ATI-2173 and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

Timeline

Start
2021-03-30
Primary completion
2022-09-01
Completion
2022-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject FOSCLEVUDINE ALAFENAMIDE Other / unclassified — Oral
Subject Imdusiran Small interfering RNA (siRNA) — Subcutaneous
Comparator Tenofovir disoproxil fumarate Small molecule — —

Indications

chronic hepatitis B virus infection hepatitis D virus infection