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NCT05418868 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.

Recruiting
Registry status
Phase 1
Development phase
214
Enrollment target
3
Study locations

NCT05418868 is a Phase 1 study of HIV Infections that is actively recruiting participants, run by ViiV Healthcare. The registered enrollment target is 214 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (52% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05418868, a Phase 1 study of HIV Infections, is actively recruiting participants, sponsored by ViiV Healthcare.

RECRUITING
Registry status
Phase 1
Development phase
214 participants
Enrollment target
3
Study locations

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 Studied

HIV Infections

Interventions

  • DRUG Cabotegravir 200 mg/mL
  • DRUG Cabotegravir >=400 mg/mL
  • DRUG Cabotegravir Formulation I
  • DRUG CAB Formulation J
  • DRUG rHuPH20

Study Locations (3)

Florida

  • GSK Investigational Site - Orlando

Nevada

  • GSK Investigational Site - Las Vegas

Texas

  • GSK Investigational Site - Austin

Trial Details

FieldValue
Enrollment Target 214 participants
Start Date 2022-06-14
Est. Completion 2027-06-08
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05418868

The ClinicalTrials.gov registry entry for NCT05418868 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (52% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Cabotegravir 200 mg/mL is the first listed.

NCT05418868 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Nevada, Texas.

Frequently Asked Questions

What is clinical trial NCT05418868 about?

NCT05418868 is a clinical study titled "A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants". 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 singl...

What is the current status of trial NCT05418868?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 214 participants. The study started on 2022-06-14. Estimated completion is 2027-06-08.

What conditions does trial NCT05418868 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT05418868?

The interventions under investigation include: Cabotegravir 200 mg/mL (DRUG), Cabotegravir >=400 mg/mL (DRUG), Cabotegravir Formulation I (DRUG), CAB Formulation J (DRUG), rHuPH20 (DRUG).

Who is sponsoring clinical trial NCT05418868?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05418868 being conducted?

This trial has 3 study locations across Florida, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.