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RECRUITING
NCT05418868
PHASE1

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

Sponsor: ViiV Healthcare

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2022-06-14

Completion Date

2027-06-08

Last Updated

2025-12-18

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Cabotegravir 200 mg/mL

CAB 200 mg/mL will be administered.

DRUG

Cabotegravir >=400 mg/mL

CAB \>=400 mg/mL will be administered by IM or SC injection.

DRUG

Cabotegravir Formulation I

CAB Formulation I will be administered by IM injection.

DRUG

CAB Formulation J

CAB Formulation J will be administered by IM injection.

DRUG

rHuPH20

rHuPH20 will be administered.

DRUG

RPV

RPV will be administered by IM injection.

Locations (3)

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Austin, Texas, United States