IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study

This is a phase 1, open-label, dose-escalation, study of IAP086 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to characterize the safety, tolerability, and pharmacokinetics (PK) of the study drug in healthy PWH suppressed on ART. The participant's standard of care ART regimen is continued throughout the study period. The study will evaluate single ascending doses of IAP086 with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9. Given the focus of this study is on safety, accrual within a dose cohort will be staggered such that each participant is followed for 6 days following study drug administration prior to study drug administration in a subsequent participant. A 14-day dose-limiting toxicity (DLT) period is observed prior to escalation to the next dose cohort level. Dose escalation proceeds until cell-associated HIV RNA induction (see below) or drug-related DLT criteria to halt escalation are met. This study is designed to limit study drug exposures to participants due to the exploratory nature of this first-in-human study and effects seen after multiple doses in non-clinical toxicology studies. An adaptive dose escalation strategy will be used. This study will have up to 9 dose cohorts starting at 0.3 µg/kg. Participants in each dose cohort will be dosed sequentially. Each participant will be directly monitored for safety for at least 24 hours after dosing, with a 6-day period of safety observations completed prior to dosing of the next participant in the same dose cohort. The study will evaluate single ascending doses of IAP086 by intravenous (IV) infusion with a 1+3 design for cohorts 1-3, followed by a 3+3 design for cohorts 4-9.If no dose limiting toxicities occur in the 1 participant in cohorts 1-3 or 3 participants in cohorts 4-9, the study proceeds to the next higher dose following Safety Monitoring Committee (SMC) review. All cohorts can be expanded to include an additional +3 participants if a treatment related DLT is observed to more fully explore safety events, clinical laboratory results, and virological or biomarker data prior to escalating to the next dose cohort.