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

NCT05850728 PHASE1 COMPLETED

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 is designed to learn whether the formulation can be used as a platform for other drugs for treatment of HIV. The formulation is a drug combination nanoparticle (DCNP). The study will be conducted by UW Positive Research. The sample size for this study is 12-16. The study population consists of healthy adults without HIV. The study duration is 57 days per participant at the start of the study.

Details

Lead sponsorUniversity of Washington
PhasePHASE1
StatusCOMPLETED
Enrolment12
Start dateSat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States