Trials / Completed
CompletedNCT05039099
A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacodynamic Markers, and Pharmacokinetics of AP-101 in Patients With Familial Amyotrophic Lateral Sclerosis (fALS) and Sporadic Amyotrophic Lateral Sclerosis (sALS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- AL-S Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AP-101 | Participants receive AP-101 by intravenous infusion (IV). |
| DRUG | Placebo | Participants receive placebo by IV. |
Timeline
- Start date
- 2021-09-02
- Primary completion
- 2025-08-13
- Completion
- 2025-08-13
- First posted
- 2021-09-09
- Last updated
- 2025-08-19
Locations
13 sites across 6 countries: United States, Belgium, Canada, Germany, South Korea, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05039099. Inclusion in this directory is not an endorsement.