A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients W
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
What it found
No result yet.
What was tested
Treatment tested
- PRO-1562 Oral Capsules
Placebo
- Placebo Oral Capsule
What it measured
Main measures
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events
From enrollment until 7 days post dose
SafetyPhase 2 Change from baseline P100 VEP latency
From enrollment until the end of 6 months of treatment
Myelin repair
Other measures (3)
Area under the concentration-time curve of PRO-1562 (Phase 1)
From enrollment until 7 days post dose.
Brain myelin content, change from baseline
From enrollment to the end of 6 months of treatment
MRI lesionsMyelin repairSafety Phase 2 Incidence of ≥Grade 2 treatment-emergent adverse events
From enrollment until the end of 6-months of treatment
Safety
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Oct 2026
Main results due
Dec 2028
Finished
Feb 2029