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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of Prosetin in Healthy Volunteers and Participants With Amyotrophic Lateral Sclerosis (ALS) With an Optional Open-Label Extended Treatment Period for ALS Participants Who Complete 14 Days of Blinded Treatment

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Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of Prosetin in Healthy Volunteers and Participants With Amyotrophic Lateral Sclerosis (ALS) With an Optional Open-Label Extended Treatment Period for ALS Participants Who Complete 14 Days of Blinded Treatment

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Apr 2025

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At a glance

  • Drugs Prosetin (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions
  • Acronyms PRO-101
  • Sponsors ProJenX

Most Recent Events

  • 04 Mar 2025 Planned number of patients changed from 32 to 72.
  • 04 Mar 2025 Planned End Date changed from 1 Jul 2022 to 31 Oct 2026.
  • 04 Mar 2025 Planned primary completion date changed from 1 May 2022 to 30 Jun 2026.

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