A Phase 1a Trial Assessing the Safety, Tolerability, and Immunogenicity of GS-4774 (GI-13020) at Various Dose Levels and Regimens in Healthy Adults

Phase 1 Completed 60 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial will be test the safety, tolerability, and immunogenicity of GS-4774 (GI-13020) in various doses and dosing regimens in healthy adults at one center in the US. Subjects will be enrolled into 3 arms using a dose escalation scheme and randomized into one of two dosing regimen cohorts. There will be 10 subjects per arm/cohort (total of 60 subjects to achieve 48 evaluable subjects enrolled), with study completion in 9-12 months.

Timeline

Start: 2013-01
Primary completion: 2013-08
Completion: 2013-08

Publications

Gaggar A, Coeshott C, Apelian D, Rodell T, Armstrong BR, Shen G, Subramanian GM, McHutchison JG. Safety, tolerability and immunogenicity of GS-4774, a hepatitis B virus-specific therapeutic vaccine, in healthy subjects: a randomized study. Vaccine. 2014 Sep 3;32(39):4925-31. doi: 10.1016/j.vaccine.2014.07.027. Epub 2014 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GS-4774	Vaccine	10 unknown	Subcutaneous
Subject	GS-4774	Vaccine	40 unknown	Subcutaneous
Subject	GS-4774	Vaccine	80 unknown	Subcutaneous

Indications

No indication recorded.