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

NCT05418868 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-12-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Janssen Sciences Ireland Unlimited Company

    collaborator UNKNOWN

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2027-06-08
Completion
2027-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418868 on ClinicalTrials.gov