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NCT03945279 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis

A Phase 1 study, sponsored by Biogen.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT03945279 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 49 participants.

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The verdict

NCT03945279, a Phase 1 study, has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG BIIB100

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2019-05-30
Est. Completion 2021-06-21
Phase Phase 1

Sponsor

Biogen

334 total trials

What the Registry Record Tells You About NCT03945279

The ClinicalTrials.gov registry entry for NCT03945279 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03945279 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03945279 about?

NCT03945279 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis". 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.

What is the current status of trial NCT03945279?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2019-05-30. Estimated completion is 2021-06-21.

What interventions are being tested in trial NCT03945279?

The interventions under investigation include: Placebo (DRUG), BIIB100 (DRUG).

Who is sponsoring clinical trial NCT03945279?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.