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NCT07826689From ClinicalTrials.govRecruiting

A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Trial of PRO-1562 in Healthy Adults and Adults With Multiple Sclerosis and Chronic Optic Neuropathy

  • Multiple Sclerosis

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Progentos Therapeutics
Enrolment target
160
Started
October 2026
Main results due
December 2028
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Ages 18 years to 65 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Phase 1 Inclusion Criteria:

1. Able and willing to provide written informed consent
2. Body weight ≥ 48 kg (105.6 lbs) and body mass index (BMI) ≥ 18.5 and ≤ 30 kg/m2
3. Must be in good health and without clinically significant abnormalities by review of medical and surgical history, physical examination, vital signs measurement, and 12-lead ECG
4. No clinically-significant laboratory abnormalities
5. Willing and able to use highly-effective forms of contraception for at least 30 days after the end of study visit.

Phase 1 Exclusion Criteria:

1. Ongoing medical condition requiring systemic therapy.
2. Ongoing infection
3. mRNA or live vaccine during the past 60 days
4. History of significant hypersensitivity, intolerance, or allergy to any drug/medication
5. Participation in another clinical trial with an investigational agent within 30 days prior to Check-in or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer
6. Positive alcohol breath test or urine screen for drugs of abuse.
7. Use or intent to use natural products or nutritional/dietary supplements (including St. John's wort), vitamins, minerals, and phytotherapeutic /herbal/plant-derived preparations within or received within 14 days or 5 half-lives prior to Check-in, whichever is longer.
8. Poor peripheral venous access.
9. Receipt of blood products within 2 months prior to Check-in.
10. Donation of blood or blood products during the 4 weeks prior to Check-in.
11. Participants who in the opinion of the Principal Investigator (or designee), should not participate in this study

What this study is about

In the sponsor’s own words, from the registry.

Phase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body. Some subjects will have lumbar punctures performed to measure the amount of drug that crosses the blood-brain barrier since that is the site of drug activity.

Phase 2a will be a 6-month trial to test the ability of once monthly dosing of PRO-1562 to promote remyelination of the CNS and provide clinical benefit to adult patients with relapsing multiple sclerosis (RMS) who also have long-term vision problems diagnosed as chronic optic neuropathy. The benefits of remyelination will be measured using tests of visual acuity, speed of optic nerve conduction signals, and clinical assessments of cognitive and motor function. PRO-1562 will be added on to a stable regimen of MS disease modifying therapy.

Study sites(1)

  • CMAX Clinical Research

    Adelaide, South Australia, Australia

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07826689. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis | Trialion