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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GS-5745 SC

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

Group Type EXPERIMENTAL

GS-5745 SC

Intervention Type DRUG

GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe

GS-5745 IV

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

Group Type EXPERIMENTAL

GS-5745 IV

Intervention Type DRUG

GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials

Interventions

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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

Intervention Type DRUG

GS-5745 IV

GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes