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

NCT05807971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Athos Therapeutics Australia Pty Ltd

    collaborator UNKNOWN

  • Athos Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05807971 on ClinicalTrials.gov