A Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis
11. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
160
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Chief Medical Officer
- Telefonnummer: 858-306-2085
- E-post: pfrohna@progentos.com
Studiesteder
-
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South Australia
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Adelaide, South Australia, Australia, 5000
- CMAX Clinical Research
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Ta kontakt med:
- Study Director
- Telefonnummer: 61 1800 150 433
- E-post: cmax@cmax.com.au
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Phase 1, PRO-1562 Dose level 1
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentell: Phase 1, PRO-1562 Dose level 2
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentell: Phase 1, PRO-1562 Dose level 3
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentell: Phase 1, PRO-1562 Dose level 4
PRO-1562 oral capsules
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentell: Phase 1, PRO-1562 Dose level 5
PRO-1562 oral capsule
|
Oral, CNS-penetrant small molecule designed to induce remyelination
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Paul A Frohna, MD, PhD, PharmD, Progentos Therapeutics
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. februar 2029
Datoer for studieregistrering
Først innsendt
8. september 2026
Først innsendt som oppfylte QC-kriteriene
11. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO-1562-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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