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
Latest Information Update: 21 Jun 2024
At a glance
- Drugs SPG 302 (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Adverse reactions; First in man
- Sponsors Spinogenix
- 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.
- 05 Jun 2024 Planned primary completion date changed from 1 May 2024 to 1 May 2025.