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

Phase 1
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: GS-5745 SC
Drug: GS-5745 IV
Registration Number
NCT02209987
Lead Sponsor
Gilead Sciences
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
GS-5745 SCGS-5745 SCParticipants will receive a single dose of GS-5745 by SC injection.
GS-5745 IVGS-5745 IVParticipants will receive a single dose of GS-5745 by IV infusion.
Primary Outcome Measures
NameTimeMethod
PK profile of GS-5745Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8

This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:

* Cmax: maximum observed concentration of drug in plasma

* AUClast: concentration of drug from time zero to the last quantifiable concentration

* AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity

Secondary Outcome Measures
NameTimeMethod
Incidences of adverse events and laboratory abnormalitiesUp to 8 weeks

This composite endpoint will measure the safety and tolerability profile of GS-5745.

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