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 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.
Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures.
Males and females 18-60 years of age, inclusive.
Medically healthy by history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations (hematology, serum chemistry, coagulation, urinalysis).
Body mass index (BMI) of 18.0-35.0 kg/m2, inclusive.
1. Any clinically significant disease or condition which, in the opinion of the Investigator, could affect participant safety or confound study results.
Hemoglobin <10 g/dL
White blood cells <3.0 × 103/μL
Neutrophils ≤1500/μL
Parallel
ATI-105
DrugATI-105 is manufactured as an oral capsule containing astaxanthin, botanical drug product
Placebo
DrugATI-105 matching placebo capsule
Reporting of treatment-emergent adverse events and serious adverse events
incidence and severity of adverse events
Change from baseline to end of study of pharmacokinetic parameter Maximum observed plasma drug Concentration (Cmax)
Change from baseline to end of study of pharmacokinetic parameter Time to maximum observed plasma drug concentration (Tmax)
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)
Change from baseline to end of study of pharmacokinetic parameter AUC extrapolated to infinity
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Adjuvia Therapeutics, Inc.
Lead sponsor
Quotient Sciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
