A Phase 1 interventional study of ATI-105 and Placebo in Friedreich Ataxia, Cardiomyopathies and Central Nervous System Diseases, sponsored by Adjuvia Therapeutics, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Adjuvia Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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:
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 will randomly be assigned to one of three dose groups to receive a single dose of ATI-105 or a placebo. Some of the participants will receive a second dose to inform whether ATI-105 should be taken with or without food. Qualifying participants who enroll into the second study portion will receive ATI-105 or placebo for 14 days and will be randomly assigned to one of three dosing groups.
For both portions, a safety committee will review the safety and tolerability data for each dosing group to determine if the dose can be increased for the next dosing group.
Participants will be required to stay over night in the clinic for a few days and come back for visits after for procedures that include a check of their vitals and blood draws.
111 studies on the registry are indexed under Friedreich Ataxia; 28 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 76 interventional studies indexed under Friedreich Ataxia.
Browse Friedreich Ataxia studies →This is the only study on the registry with Adjuvia Therapeutics, Inc. as lead sponsor.
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Exclusion Criteria:
1. Any clinically significant disease or condition which, in the opinion of the Investigator, could affect participant safety or confound study results.
2. Pregnant or lactating subjects. 3. Use of prescription/over-the-counter (OTC) medications, herbal products, or supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing, or current use of any investigational medication. Thyroid medications with a stable dose for 1 year are acceptable.
4. Use of glucagon-like peptide-1 (GLP-1) agonists. 5. Positive test for drugs of abuse or alcohol. 6. Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), per institutional laboratory test.
7. Positive test for influenza or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), positive test for SARS-CoV-2 within 30 days prior to screening, or current long COVID.
8. Laboratory abnormalities including but not limited to:
ATI-105 oral single or multiple ascending doses
Drug: ATI-105
Matching placebo control capsule
Drug: Placebo
ATI-105 is manufactured as an oral capsule containing astaxanthin, botanical drug product
ATI-105 matching placebo capsule
Reporting of treatment-emergent adverse events and serious adverse events
incidence and severity of adverse events
Time frame: 8-21 days
Change from baseline to end of study of pharmacokinetic parameter Maximum observed plasma drug Concentration (Cmax)
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter Time to maximum observed plasma drug concentration (Tmax)
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter Area under the plasma-drug concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter AUC extrapolated to infinity
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter AUC over the dosing interval (tau)
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter Apparent terminal phase elimination rate constant
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter Apparent plasma clearance
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Change from baseline to end of study of pharmacokinetic parameter Apparent volume of distribution at the terminal phase, if appropriate
Time frame: Multiple on Days 1-7 or Days 1-2 and Days 14-20
Plan to share: Yes — Principal Investigator
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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