Trials / Completed
CompletedNCT03945279
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis
A Phase 1, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adult Participants With Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety, tolerability of single-ascending doses of BIIB100 in adults with amyotrophic lateral sclerosis (ALS). The secondary objective of the study is to characterize the pharmacokinetic profile of BIIB100.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB100 | Administered as specified in the treatment arm. |
| DRUG | Placebo | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2019-05-30
- Primary completion
- 2021-06-21
- Completion
- 2021-06-21
- First posted
- 2019-05-10
- Last updated
- 2023-04-18
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03945279. Inclusion in this directory is not an endorsement.