A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis
11. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
160
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Chief Medical Officer
- Telefonnummer: 858-306-2085
- E-mail: pfrohna@progentos.com
Studiesteder
-
-
South Australia
-
Adelaide, South Australia, Australien, 5000
- CMAX Clinical Research
-
Kontakt:
- Study Director
- Telefonnummer: 61 1800 150 433
- E-mail: cmax@cmax.com.au
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Phase 1, PRO-1562 Dose level 1
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentel: Phase 1, PRO-1562 Dose level 2
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentel: Phase 1, PRO-1562 Dose level 3
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentel: Phase 1, PRO-1562 Dose level 4
PRO-1562 oral capsules
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentel: Phase 1, PRO-1562 Dose level 5
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentel: Phase 1, PRO-1562 Dose level 6
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Placebo komparator: Phase 1, Placebo
Placebo oral capsule
|
Placebo filled capsules that look like the active intervention
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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 komparator: Phase 2, Placebo
Placebo oral capsule
|
Placebo filled capsules that look like the active intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 1 Incidence of ≥Grade 2 treatment-emergent adverse events
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the concentration-time curve of PRO-1562 (Phase 1)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Paul A Frohna, MD, PhD, PharmD, Progentos Therapeutics
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. februar 2029
Datoer for studieregistrering
Først indsendt
8. september 2026
Først indsendt, der opfyldte QC-kriterier
11. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO-1562-101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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