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

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

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 4. To compare lymphoid tissue mononuclear cell versus PBMC concentrations of the drug substances in TLC-ART 101. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05850728
Study type	Interventional
Source	University of Washington
Contact	UW Positive Research
Phone	206-773-7129
Email	positiveresearch@uw.edu
Status	Recruiting
Phase	Phase 1
Start date	April 1, 2023
Completion date	December 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.