NCT02209987

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

A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	GS-5745 SC	GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
DRUG	GS-5745 IV	GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-08-06
• Last updated: 2014-10-27

Locations

1 site across 1 country: New Zealand