Pure Global AI
ANZCTR12623000536662Not yet recruiting

GS-US-200-5710: A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular Lenacapavir

Gilead SciencesPhase 1Australian New Zealand Clinical Trials Registrydrug
VerifiedAustralian New Zealand Clinical Trials Registry
Study focus
Disease/Condition
HIV
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Gilead Sciences
Location
New Zealand;United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 31, 2023
End date
May 31, 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 monthly to twice-yearly, for use in the prevention of HIV-1 infection

ICD-10 classifications
Human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHIV disease resulting in other viral infectionsUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other specified diseases
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000536662
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12623000536662 through Pure Global AI's free database. This Phase 1 trial is sponsored by Gilead Sciences and is currently Not yet recruiting. The study focuses on HIV.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.