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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus Treatment Antiretroviral Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Pharmacologically-guided adaptive design, in which the dose is increased or decreased if needed, based on results from prior participant arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TLC-ART 101 Initial Dosage

The arms will all receive the nanoparticle suspension of lopinavir, ritonavir, and tenofovir (TLC-ART 101). The arms are also called cohorts. The dose a participant receives will vary, depending upon the study results and the time of when they enroll in the study.

The initial dosage administered to 4 participants will contain:

lopinavir 15.6 mg, ritonavir 4.2 mg, and tenofovir 9.15 mg in 1.5mL of the formulation

If the initial dose is appropriate, an additional 8 participants will be enrolled in Arm 1, for a total study size of 12 participants.

Group Type EXPERIMENTAL