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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: GS-5745 SC
* Drug: GS-5745 IV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS-5745 SC<br>Participants will receive a single dose of GS-5745 by SC injection. | Drug: GS-5745 SC<br>* GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe<br>|
| Experimental: GS-5745 IV<br>Participants will receive a single dose of GS-5745 by IV infusion. | Drug: GS-5745 IV<br>* GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of GS-5745 | 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 | Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of adverse events and laboratory abnormalities | This composite endpoint will measure the safety and tolerability profile of GS-5745. | Up to 8 weeks |