Oral PRO-1562 in healthy adults and people with relapsing MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Phase 1 will evaluate the safety and how the drug behaves in the body after single rising doses in healthy volunteers, including how much gets into the cerebrospinal fluid. Phase 2a will enroll adults with relapsing MS and chronic optic neuropathy to receive monthly PRO-1562 or placebo for six months in addition to their current MS therapy, to see if it promotes remyelination and improves vision, cognition, and movement. The trial is randomized, double-blind, and placebo-controlled, conducted at multiple centers with a single ascending-dose phase at the start. Participants will be followed for potential continued treatment after the main 6-month period.

Why it matters

Who can join: the full rules

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

Where it's running

• CMAX Clinical Research
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Study coordinator: Chief Medical Officer
• Email: pfrohna@progentos.com
• Phone: 858-306-2085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treadmill-based virtual reality walking training for MS patients

  This study tests whether a treadmill with virtual reality and smart socks can help people with multiple sclerosis walk better and feel safer in daily life.

  Recruiting Shepherd Center, Atlanta GA · Atlanta, Georgia · NCT07927439

• Virtual Reality and Mental Practice to Improve Balance and Walking in Relapsing MS

  This study tests whether virtual reality training or mental practice can improve balance and walking in people with relapsing–remitting multiple sclerosis.

  Recruiting Cairo University · Giza, Giza Governorate · NCT07918339

• REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care

  This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.

  Recruiting Imperial College London · London and 2 other locations · NCT07899502

• Tolebrutinib in real-world MS care for patients treated by clinicians

  This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.

  Recruiting Sanofi · Marina, Abu Dhabi Emirate · NCT07898371

• Pilates via live video vs. prerecorded videos for people with multiple sclerosis

  This study tests whether live, coach-led Pilates sessions through video calls are more beneficial than prerecorded Pilates videos for adults with MS.

  Recruiting Yuzuncu Yil University · Van · NCT07893925

• Cooling During Inpatient Rehab for People with MS

  This trial tests whether wearing a cooling vest during intensive training can reduce fatigue and improve walking, strength, balance, and cognition in people with multiple sclerosis during a 3-week inpatient rehab stay.

  Recruiting Klinik Valens · Valens, Canton of St. Gallen · NCT07852156

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.