Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients

Phase 1 Completed 55 enrolled Novira Therapeutics, Inc.

RandomizedSingle-groupTriple-blindTreatment

Summary

This Phase 1 trial will assess the dose-related safety and PK profile of different doses of NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.

Timeline

Start: 2014-04-30
Primary completion: 2016-05-18
Completion: 2016-05-18

Publications

Yuen MF, Gane EJ, Kim DJ, Weilert F, Yuen Chan HL, Lalezari J, Hwang SG, Nguyen T, Flores O, Hartman G, Liaw S, Lenz O, Kakuda TN, Talloen W, Schwabe C, Klumpp K, Brown N. Antiviral Activity, Safety, and Pharmacokinetics of Capsid Assembly Modulator NVR 3-778 in Patients with Chronic HBV Infection. Gastroenterology. 2019 Apr;156(5):1392-1403.e7. doi: 10.1053/j.gastro.2018.12.023. Epub 2019 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NVR 3-778	Unknown	100 mg	Oral
Subject	NVR 3-778	Unknown	200 mg	Oral
Subject	NVR 3-778	Unknown	400 mg	Oral
Subject	NVR 3-778	Unknown	600 mg	Oral
Subject	NVR 3-778	Unknown	1000 mg	Oral
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	—	Subcutaneous

Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients

Summary

Timeline

Publications

Drugs

Indications