NCT05807971

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ATH-063 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Athos Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Primary Objective of this study will be to evaluate the safety and tolerability of ATH-063 following oral administration of single and multiple ascending doses (SAD/MAD) in healthy subjects. This is a single center, Phase 1, Randomized, Double-blind, Placebo controlled, sequential SAD/MAD study, with a food-effect arm. The study will be divided into three parts: * SAD cohorts * MAD cohorts * Food-effect (FE) cohort MAD and FE cohorts will be dosed in parallel after the completion of the SAD Cohorts SAD Part: 1. Consist of at least 4 cohorts (1 cohort per dose level). 2. Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo). 3. A staggered dosing schedule will be used for dosing of each cohort (under fasting conditions) MAD Part: 1. Consist of up to 4 cohorts (1 cohort per dose level). 2. Each cohort will include approximately 8 participants (6 participants receiving the active and 2 participants receiving the placebo). 3. The cohorts will be dosed sequentially in an ascending fashion. 4. The dose of MAD cohorts is dependent on the available safety, tolerability, and PK data from the SAD part and available safety, tolerability, and PK data from dosed MAD cohorts. Food-effect Part: 1. Approximately twelve (12) participants will be randomized in a 1:1 ratio to one of two treatment sequences (fast-fed/fed-fast) with 6 participants per treatment sequence. 2. The selection of the dose to be administered in the food effect part will depend on the results of the SAD part following the review of safety, tolerability and PK data of the SAD cohorts.

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis
• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	ATH-063	12.5 and 50 mg Capsules, anticipated dose range to be from 25 to 250 mg.
DRUG	Placebo	Identical capsule to the drug without the active ingredient.

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-02-08
• Completion: 2024-02-08
• First posted: 2023-04-11
• Last updated: 2024-05-03

Locations

1 site across 1 country: Australia