NCT05418868

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-14
• Primary completion: 2027-06-08
• Completion: 2027-06-08
• First posted: 2022-06-14
• Last updated: 2025-12-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study