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A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)

NCT05039099 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-08-19

No results posted yet for this study

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

DRUG

AP-101

Participants receive AP-101 by intravenous infusion (IV).

DRUG

Placebo

Participants receive placebo by IV.

Sponsors & Collaborators

  • AL-S Pharma

    lead INDUSTRY

Principal Investigators

  • Study Director · AL-S Pharma SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-02
Primary Completion
2025-08-13
Completion
2025-08-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • South Korea
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039099 on ClinicalTrials.gov