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

NCT02209987 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-10-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bittoo Kanwar, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • New Zealand

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209987 on ClinicalTrials.gov