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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: GS-5745 SC; Drug: GS-5745 IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209987

GS-US-326-1430

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

GS-5745 SC

Experimental group

Description:

Participants will receive a single dose of GS-5745 by SC injection.

Treatment:

Drug: GS-5745 SC

GS-5745 IV

Experimental group

Description:

Participants will receive a single dose of GS-5745 by IV infusion.

Treatment:

Drug: GS-5745 IV