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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 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 sponsor | University of Washington |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Human Immunodeficiency Virus
- Treatment
- Antiretroviral Therapy
Interventions
- TLC-ART
Countries
United States