Can a pill rebuild the Brain's insulation? MS trial puts remyelination to the test
NCT ID NCT07826689
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing an experimental oral drug called PRO-1562 in healthy adults and in adults with relapsing multiple sclerosis who also have long-term vision damage from chronic optic neuropathy. The trial has two parts: a phase 1 safety and absorption study in healthy volunteers, and a 6-month phase 2a study in MS patients that measures whether monthly doses improve vision, nerve signaling, and brain myelin. PRO-1562 is designed to cross into the brain and encourage remyelination, the repair of the protective coating around nerves. Participants in the phase 2a portion continue their regular MS disease-modifying therapy while adding PRO-1562 or a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRO-1562, an experimental oral drug designed to prompt the body to rebuild myelin
- What this could lead to
- If PRO-1562 works, it could become a treatment that repairs myelin damage in multiple sclerosis and possibly restore lost vision or movement.
- What could go wrong
- This is an early-stage trial with 160 participants, so most drugs at this stage fail or show only modest effects. PRO-1562 may not cross into the brain well enough, may cause side effects, or may not repair myelin in people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CMAX Clinical Research
Adelaide, South Australia, 5000, Australia
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