NCT07826689 A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis
| NCT ID | NCT07826689 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Progentos Therapeutics |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-10 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2026-10 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Paul A Frohna, MD, PhD, PharmD
STUDY CHAIR
Progentos Therapeutics
Frequently Asked Questions
Who can join the NCT07826689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07826689 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07826689 currently recruiting?
Yes, NCT07826689 is actively recruiting participants. Contact the research team at pfrohna@progentos.com for enrollment information.
Where is the NCT07826689 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT07826689 clinical trial?
NCT07826689 is sponsored by Progentos Therapeutics. The principal investigator is Paul A Frohna, MD, PhD, PharmD at Progentos Therapeutics. The trial plans to enroll 160 participants.
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