A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis
11 september 2026 bijgewerkt door: Progentos Therapeutics
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
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Phase 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) trial of PRO-1562 in healthy adult participants at a single clinical research unit to characterize the safety and pharmacokinetics of a range of oral doses of PRO-1562.
Phase 2a is a randomized, double-blind, placebo-controlled, multi-center, 6-month trial of PRO-1562 in adult patients with relapsing multiple sclerosis who also have chronic optic neuropathy.
Patients will remain on their stable regimen of an approved MS disease modifying therapy during the trial.
Oral PRO-1562 or placebo will be dosed once a month at scheduled clinic visits.
Participants will be given the option to continue on their assigned study treatment after completing the 6-month treatment period until the last patient completes the 6-month treatment period.
Studietype
Ingrijpend
Inschrijving (Geschat)
160
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Chief Medical Officer
- Telefoonnummer: 858-306-2085
- E-mail: pfrohna@progentos.com
Studie Locaties
-
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South Australia
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Adelaide, South Australia, Australië, 5000
- CMAX Clinical Research
-
Contact:
- Study Director
- Telefoonnummer: 61 1800 150 433
- E-mail: cmax@cmax.com.au
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Phase 1 Inclusion Criteria:
- Able and willing to provide written informed consent
- Body weight ≥ 48 kg (105.6 lbs) and body mass index (BMI) ≥ 18.5 and ≤ 30 kg/m2
- 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
- No clinically-significant laboratory abnormalities
- 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:
- Ongoing medical condition requiring systemic therapy.
- Ongoing infection
- mRNA or live vaccine during the past 60 days
- History of significant hypersensitivity, intolerance, or allergy to any drug/medication
- 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
- Positive alcohol breath test or urine screen for drugs of abuse.
- 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.
- Poor peripheral venous access.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood or blood products during the 4 weeks prior to Check-in.
- Participants who in the opinion of the Principal Investigator (or designee), should not participate in this study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Phase 1, PRO-1562 Dose level 1
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Experimenteel: Phase 1, PRO-1562 Dose level 2
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Experimenteel: Phase 1, PRO-1562 Dose level 3
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Experimenteel: Phase 1, PRO-1562 Dose level 4
PRO-1562 oral capsules
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Experimenteel: Phase 1, PRO-1562 Dose level 5
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Experimenteel: Phase 1, PRO-1562 Dose level 6
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Placebo-vergelijker: Phase 1, Placebo
Placebo oral capsule
|
Placebo filled capsules that look like the active intervention
|
|
Experimenteel: Phase 2, PRO-1562 Oral Capsules Dose level 1
PRO-1562 low dose level selected from Phase 1 (oral capsule)
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Experimenteel: Phase 2, PRO-1562 Oral Capsules Dose level 2
PRO-1562 high dose level selected from Phase 1 (oral capsule)
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Placebo-vergelijker: Phase 2, Placebo
Placebo oral capsule
|
Placebo filled capsules that look like the active intervention
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events
Tijdsspanne: From enrollment until 7 days post dose
|
Incidence of treatment-emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in healthy participants
|
From enrollment until 7 days post dose
|
|
Phase 2 Change from baseline P100 VEP latency
Tijdsspanne: From enrollment until the end of 6 months of treatment
|
The change from baseline on visual evoked potential (VEP) in affected eye of RMS patients after 6 months of study treatment
|
From enrollment until the end of 6 months of treatment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Area under the concentration-time curve of PRO-1562 (Phase 1)
Tijdsspanne: From enrollment until 7 days post dose.
|
Concentration over time analysis to determine overall exposure to PRO-1562 by dose group
|
From enrollment until 7 days post dose.
|
|
Brain myelin content, change from baseline
Tijdsspanne: From enrollment to the end of 6 months of treatment
|
MRI measurement of brain myelin content in multiple brain regions will be determined as baseline and after 6 months of treatment
|
From enrollment to the end of 6 months of treatment
|
|
Safety Phase 2 Incidence of ≥Grade 2 treatment-emergent adverse events
Tijdsspanne: From enrollment until the end of 6-months of treatment
|
Incidence of treatment emergent adverse events including clinically significant laboratory abnormalities of ≥Grade 2 in RMS patients
|
From enrollment until the end of 6-months of treatment
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Paul A Frohna, MD, PhD, PharmD, Progentos Therapeutics
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 oktober 2026
Primaire voltooiing (Geschat)
1 december 2028
Studie voltooiing (Geschat)
1 februari 2029
Studieregistratiedata
Eerst ingediend
8 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 september 2026
Eerst geplaatst (Werkelijk)
17 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
11 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRO-1562-101
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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