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Study identifier: NCT05418868 Synced from ClinicalTrials.gov · July 30, 2026
● Recruiting

A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Condition: HIV Infections  ·  Sponsor: ViiV Healthcare

PhasePhase 1
Planned participants214
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersYes

About this study

This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.

This description comes directly from the study's public registry record.

Talk to the study team

US GSK Clinical Trials Call Center  ·  877-379-3718  ·  GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center  ·  +44 (0) 20 89904466  ·  GSKClinicalSupportHD@gsk.com

Always discuss trial participation with your own doctor first.

Locations (3)

GSK Investigational SiteOrlando, Florida, United StatesCompleted
GSK Investigational SiteLas Vegas, Nevada, United StatesRecruiting
GSK Investigational SiteAustin, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05418868