Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07869654

PHASE1

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

Sponsor: Adjuvia Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ATI-105 in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-26

Completion Date

2027-06-27

Last Updated

2026-10-09

Healthy Volunteers

Yes

Conditions

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

Interventions

DRUG

ATI-105

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

DRUG

Placebo

ATI-105 matching placebo capsule

Inclusion Criteria: 1. Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures. 2. Males and females 18-60 years of age, inclusive. 3. Medically healthy by history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations (hematology, serum chemistry, coagulation, urinalysis). 4. Body mass index (BMI) of 18.0-35.0 kg/m2, inclusive. 5. Able to swallow capsules. 6. 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). 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: 1. Hemoglobin \<10 g/dL 2. White blood cells \<3.0 × 103/μL 3. Neutrophils ≤1500/μL 4. Platelet count \<150 × 109/L 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal (ULN) 6. Total bilirubin \>1.2 mg/dL 7. Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2

Locations (1)

Quotient Sciences

Miami, Florida, United States