drugset / Trial / NCT05807971

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects

NCT05807971 ↗

RandomizedSequentialQuadruple-blindTreatment

Summary

The goal of this clinical trial is to test the ATH-063 drug (single and multiple doses) in Healthy Subjects. The clinical trial aims to evaluate the below. 1. Safety of the drug 2. Tolerability of the drug 3. Pharmacokinetics (PK) (how the human body affects the drug) 4. Pharmacodynamics (PD) (how the drug affects the human body) This will be a single center, Phase 1, First-In-Human, Randomized, Double-Blind (neither the subjects nor the experimenters know which subjects are in the test and control groups), Placebo (a look-alike substance that contains no active drug) - Controlled Study.

Timeline

Start
2023-04-06
Primary completion
2024-02-08
Completion
2024-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ATH-063 Unknown 12.5 mg Oral
Subject ATH-063 Unknown 25 mg Oral
Subject ATH-063 Unknown 50 mg Oral
Subject ATH-063 Unknown 250 mg Oral