RecruitingPhase 1NCT05418868

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


Sponsor

ViiV Healthcare

Enrollment

214 participants

Start Date

Jun 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new formulation of cabotegravir — a long-acting injectable HIV prevention and treatment medication — combined with an enzyme that may allow the injection to be given under the skin (subcutaneous) rather than into a muscle. This could make the injection easier to administer and more comfortable for patients. **You may be eligible if...** - You are between 18 and 55 years old - You are generally healthy with no significant medical conditions - You do not have HIV - You are not currently pregnant or at high risk of pregnancy during the study **You may NOT be eligible if...** - You have a history of significant heart, liver, kidney, or immune conditions - You have taken cabotegravir or similar HIV medications before - You have participated in another drug study recently - You have allergies to the study medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabotegravir 200 mg/mL

CAB 200 mg/mL will be administered.

DRUGCabotegravir >=400 mg/mL

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

DRUGCabotegravir Formulation I

CAB Formulation I will be administered by IM injection.

DRUGCAB Formulation J

CAB Formulation J will be administered by IM injection.

DRUGrHuPH20

rHuPH20 will be administered.

DRUGRPV

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

View Full Details on ClinicalTrials.gov

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NCT05418868


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