GS-US-200-5717: A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular Lenacapavir - Trial ANZCTR12623000535673
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Study Focus
Sponsor & Location
Gilead Sciences
Timeline & Enrollment
Phase 1
Oct 31, 2023
Apr 30, 2024
Primary Outcome
Safety and tolerability assessed by physical exam, injection site examinations, patient report pain questionnaire, review of concomitant medications, vitals signs, clinical laboratories (hematology, chemistry, creatinine clearance calculation, and urinalysis), serum pregnancy tests, 12-lead ECG, Adverse events and laboratory toxicities will be assessed and managed according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs, Version 2.1 dated July 2017.
Summary
This is a Phase 1, multi-centre, international, open-label study to evaluate the safety, tolerability, and pharmacokinetics of subcutaneously and intramuscularly administrated Lenacapavir in healthy participants. This study aims at further finding the drug concentration and dose required to support taking Lenacapavir at least once a year, for use in the prevention of HIV-1 infection.
ICD-10 Classifications
Data Source
Australian New Zealand Clinical Trials Registry
ANZCTR12623000535673
Non-Device Trial