ABA-101 for Multiple Sclerosis

Recruiting at 2 trial locations

Overseen By Leonard Dragone, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abata Therapeutics

Must not be taking: Disease-modifying therapies

Disqualifiers: Immunocompromised, MS relapse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis. It is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.

Will I have to stop taking my current medications?

The trial requires that participants are not currently on disease-modifying therapies (DMTs), so you would need to stop taking those medications to join.

Eligibility Criteria

This trial is for adults over 18 with progressive multiple sclerosis, confirmed by the McDonald criteria. Participants must show signs of brain inflammation on MRI, have worsening disability not linked to MS relapses, match a specific genetic marker (HLA), and meet certain physical function tests.

Inclusion Criteria

I can complete the nine-hole peg test as required.

My MS is getting worse without having relapses.

Has a diagnosis of MS per the 2017 revised McDonald criteria

Exclusion Criteria

Is considered by the Investigator to be immunocompromised

I am currently on medication to slow my disease's progression.

My condition worsened or returned within the last 24 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ABA-101, starting with a low dose followed by a high dose after safety is demonstrated

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with adverse events tracked through Day 29

4 weeks

Treatment Details

Interventions

• ABA-101

Trial Overview The study is testing ABA-101's safety and effects in humans for the first time. It starts with a low dose to ensure safety before moving on to higher doses in participants with progressive MS.

Participant Groups

Group I: ABA-101 Dose 2 Experimental Treatment 1 Intervention

High Dose ABA-101

Group II: ABA-101 Dose 1 Experimental Treatment 1 Intervention

Low Dose ABA-101

ABA-101 is already approved in United States for the following indications:

Approved in United States as ABA-101 for:

• Progressive Multiple Sclerosis (under investigation, not approved)

Who Is Running the Clinical Trial?

Abata Therapeutics

Lead Sponsor

Trials

1

Recruited

10+