drugset / Trial / NCT05807971
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATH-063 in Healthy Subjects
Phase 1
Completed
76 enrolled
Athos Therapeutics Inc
Athos Therapeutics Australia Pty Ltd · collabSyneos Health · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |