ATI-105 for Friedreich's Ataxia

LG
Overseen ByLaura Gonzalez
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Adjuvia Therapeutics, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NQ

Nester Quezada, MD

Principal Investigator

Quotient Sciences

Are You a Good Fit for This Trial?

This trial is for healthy adults who are willing to stay overnight in a clinic, take study medication (ATI-105 or placebo), and undergo blood tests and health checks. People with current illnesses or on certain medications may not be eligible.

Inclusion Criteria

Able to swallow capsules
I am medically healthy based on exams, lab tests, and heart monitoring.
Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures
See 3 more

Exclusion Criteria

Any clinically significant disease or condition which could affect participant safety or confound study results, per Investigator opinion
Positive test for drugs of abuse or alcohol
Pregnant or lactating subjects
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • ATI-105

Trial Overview

The study is testing different single and repeated doses of ATI-105 compared to a placebo in healthy adults. It aims to see how the drug works in the body, if it's safe, and whether it should be taken with food. Participants are randomly assigned to groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ATI-105Experimental Treatment1 Intervention
Group II: Placebo controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adjuvia Therapeutics, Inc.

Lead Sponsor

Quotient Sciences

Industry Sponsor

Trials
52
Recruited
1,600+