First in Human Study of TLC-ART 101 (ACTU 2001)

This study is a prospective, open-label, single-site, first-in-human study of a long-acting, injectable combination antiretroviral therapy platform, with a pharmacologically-guided adaptive design for dose escalation, de-escalation, and study duration. The study has two primary aims as follows: 1. To characterize the plasma concentration-time course and pharmacokinetics (PK) of a single dose of the drug substances of TLC-ART 101 (lopinavir, ritonavir, and tenofovir) administered by subcutaneous injection within the drug combination nanoparticle. 2. To characterize the safety and tolerability of a single subcutaneous injection of TLC-ART 101. There are 4 exploratory mechanistic objectives (with related endpoints) as follows: 1. To characterize the pharmacokinetics of the drug substances in human peripheral blood mononuclear cells (PBMCs) 2. To characterize the concentrations of intracellular TFV-diphosphate (the active moiety of TFV) in PBMCs 3. To explore whether the pharmacokinetic parameters of the 3 drug substances differ by sex following a single dose NB: This analysis not performed due to truncation of study to 3 cohorts and low ratio of female to male sex participants 4. To compare lymphoid tissue mononuclear cell versus PBMC concentrations of the drug substances in TLC-ART 101.