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A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302

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A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Single and Multiple Dose Escalation Study in Healthy Volunteers and an Expansion Cohort in Adult Participants With Amyotrophic Lateral Sclerosis (ALS) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Oct 2024

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At a glance

  • Drugs SPG 302 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; First in man
  • Sponsors Spinogenix

    • Most Recent Events

    • 01 Oct 2024 Status changed from recruiting to active, no longer recruiting.
    • 20 Jun 2024 According to a Spinogenix media release, the company has completed the Phase 1 safety study in healthy subjects in Australia and is currently being evaluated in ALS patients in Australia, with plans to enroll patients in the U.S. following recent FDA IND clearance.
    • 05 Jun 2024 Planned End Date changed from 1 Dec 2024 to 1 Dec 2025.

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