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PRO-1562 in Healthy Adults and Adults With Multiple Sclerosis and Chronic Optic Neuropathy
NCT07826689Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Progentos Therapeutics
- Drugs
- PRO-1562
- Conditions
- multiple sclerosis (MS)chronic optic neuropathy
01
Overview
Phase 2, randomised, double-blind trial of PRO-1562 in multiple sclerosis (MS) and chronic optic neuropathy (10 arms), sponsored by Progentos Therapeutics. Primary endpoints: Incidence of ≥Grade 2 treatment-emergent adverse events and Change from baseline P100 VEP latency at 6 months. Started Oct 2026; status: recruiting.
02
Design
10 arms- Study design
- RandomizedDouble-blind
Phase 1, PRO-1562 Dose level 1
PRO-1562 oral capsule
Phase 1, PRO-1562 Dose level 2
PRO-1562 oral capsule
Phase 1, PRO-1562 Dose level 3
PRO-1562 oral capsule
Phase 1, PRO-1562 Dose level 4
PRO-1562 oral capsules
Phase 1, PRO-1562 Dose level 5
PRO-1562 oral capsule
Phase 1, PRO-1562 Dose level 6
PRO-1562 oral capsule
4 more in the full profile.
03
Who it enrols
Phase 1: Healthy adults with BMI 18.5-30 kg/m2, body weight >= 48 kg, no ongoing infections or systemic therapy, willing to use contraception. Phase 2: Adults with relapsing multiple sclerosis and chronic optic neuropathy on a stable MS disease modifying therapy.
04
Endpoints
Primary
Incidence of ≥Grade 2 treatment-emergent adverse events
Change from baseline P100 VEP latency
Secondary
Area under the concentration-time curve of PRO-1562
Brain myelin content, change from baseline
Incidence of ≥Grade 2 treatment-emergent adverse events
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