Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of Long-Acting Cabotegravir with Recombinant Human Hyaluronidase PH20 in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes single doses of long-acting Cabotegravir CAB combined with Recombinant Human Hyaluronidase PH20 rHuPH20 and other formulations in healthy adult volunteers. This open-label, dose-escalation study includes several parts focusing on different dose levels and formulations, including single and repeat doses administered subcutaneously or intramuscularly. Part A has closed enrollment based on preliminary results, and Part D will not be conducted due to study design changes. Participants receive various doses and formulations of CAB, including 200 mgmL with rHuPH20, doses greater than or equal to 400 mgmL by injection, and specific formulations I and J by intramuscular injection. Rilpivirine RPV is also administered in some parts of the study intramuscularly. The study involves monitoring different dosing cohorts over set periods, with Part A and other parts having specific timelines for dosing and evaluation. During the study, participants undergo regular blood tests to measure drug levels and various health markers, including hematology and clinical chemistry parameters. Researchers track drug concentrations at multiple weeks up to 78 weeks depending on the cohort, monitor adverse events, and assess pharmacokinetic parameters such as maximum plasma concentration and half-life. Safety and tolerability are assessed throughout, with detailed laboratory and cardiac monitoring. The total study duration and follow-up periods vary by cohort and study part.

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