Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination

• Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods

• Screening laboratory evaluations must be within defined thresholds

Exclusion Criteria:

• Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)

• Pregnant and lactating females

• History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol