Phase 1Not yet recruiting
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults
A Phase 1 Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults
- Sponsor
- Adjuvia Therapeutics, Inc. (Industry)
- Enrolment
- 60 planned
- Conditions
- Friedreich Ataxia; Cardiomyopathies; Central Nervous System Diseases; Neuromuscular Diseases; Mitochondrial Diseases; Mitochondrial Dysfunction; Genetic Disease
- Interventions
- ATI-105; Placebo
- Ages
- adults
- Registry
- NCT07869654
Full record on ClinicalTrials.gov
From the registry
The goal of this clinical trial is to learn how ATI-105 administered to healthy participants at works in the body at different doses and with or without food. The outcomes of this clinical trial will help to determine if ATI-105 may be able to treat patients with Friedreich's ataxia, a rare and life-threatening nerve-muscle disease that worsens over time. The main questions this study is designed to answer include the following: * How do single doses or doses for 14 days work in the body? * Are these doses safe and tolerated? * Should ATI-105 be taken with or without food? Some participants will receive a placebo, which is an inactive substance, so the drug can be compared against it. This will help researchers determine if the drug is tolerated by participants, if there are adverse effects, and how the drug acts in the body and if there are any changes. The study will include some participants who will be assigned by chance to receive an inactive substance (placebo) that appears like the active drug product. Qualifying participants who enroll into the first of two study portions…
Primary outcomes
- Reporting of treatment-emergent adverse events and serious adverse events
History
Study completion expected
Primary completion expected
Expected to start
Registered