Overview

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

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Washington
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)