clinical trial · NCT04484337
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
ViiV Healthcare·phase1·completed·n = 138
HIV InfectionsCabotegravir sodium (Oral Lead In)Cabotegravir 400 mg/mLCabotegravir 200 mg/mLTopical Non-steroidal anti-inflammatory drug (NSAID)Topical steroidTopical NSAID placeboRecombinant human hyaluronidase PH20 (rHuPH20)Topical steroid placebo
brief summary
This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.
started
Jul 31, 2020
primary completion
May 5, 2023
completion
May 5, 2023
last updated
May 29, 2026
official title
A Phase 1, Two-part, Double-blind, Active-control, Randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Repeat-Dose Cabotegravir (CAB 400 mg/mL Formulation) Long-Acting Injection Following Subcutaneous or Intramuscular Administration in Healthy Adult Participants
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol