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

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.

Eligibility

Age range

18–55 years

Sex

All

Healthy volunteers

Yes

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)