A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults

NCT07869654 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ATI-105-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Friedreich Ataxia; Cardiomyopathies; Central Nervous System Diseases; Neuromuscular Diseases; Mitochondrial Diseases; Mitochondrial Dysfunction; Genetic Disease

Keywords

FRDA; FA; Friedreich's; neuromuscular; mitochondria; oxidative stress; astaxanthin; ATI-105; nanoemulsion; Haematococcus pluvialis algae; HP algae; antioxidant; frataxin

Outcome Measures

Primary Outcomes (1)

• Reporting of treatment-emergent adverse events and serious adverse events

  incidence and severity of adverse events

  8-21 days

Secondary Outcomes (8)

• Change from baseline to end of study of pharmacokinetic parameter Maximum observed plasma drug Concentration (Cmax)

  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)

  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)

  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

  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)

  Multiple on Days 1-7 or Days 1-2 and Days 14-20

Study Arms (2)

ATI-105

EXPERIMENTAL

ATI-105 oral single or multiple ascending doses

Drug: ATI-105

Placebo control

PLACEBO COMPARATOR

Matching placebo control capsule

Drug: Placebo

Interventions

ATI-105 DRUG

ATI-105 is manufactured as an oral capsule containing astaxanthin, botanical drug product

ATI-105

Placebo DRUG

ATI-105 matching placebo capsule

Placebo control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Able to swallow capsules.
• Males and females of childbearing potential must be willing to use an effective method of contraception (hormonal or double barrier method of birth control; abstinence) from the time consent is signed until 37 days after treatment discontinuation (i.e., 30 days + 5 half-lives of ATI-105).

You may not qualify if:

• \. Any clinically significant disease or condition which, in the opinion of the Investigator, could affect participant safety or confound study results.
• \. 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.
• \. 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.
• \. 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.
• \. Laboratory abnormalities including but not limited to:
• Hemoglobin \<10 g/dL
• White blood cells \<3.0 × 103/μL
• Neutrophils ≤1500/μL
• Platelet count \<150 × 109/L
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal (ULN)
• Total bilirubin \>1.2 mg/dL
• Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2

Sponsors & Collaborators

• Adjuvia Therapeutics, Inc.: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Friedreich Ataxia; Cardiomyopathies; Central Nervous System Diseases; Neuromuscular Diseases; Mitochondrial Diseases; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Spinocerebellar Degenerations; Cerebellar Diseases; Brain Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Nester Quezada, MD

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Gonzalez

CONTACT

305-644-9903; laura.gonzalez@quotientsciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, dose-escalation, fed/fasted

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): June 27, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)