A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety 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
Phase 1
Recruiting
- Conditions
- Amyotrophic lateral sclerosis (ALS)MedDRA version: 21.1Level: PTClassification code: 10002026Term: Amyotrophic lateral sclerosis Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-507363-20-00
- Lead Sponsor
- Projenx Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method