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

PHASE2CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

September 2, 2021

Primary Completion Date

August 13, 2025

Study Completion Date

August 13, 2025

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

AP-101

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

DRUG

Placebo

Participants receive placebo by IV.

Trial Locations (13)

3000

Department of Neurology, University Hospitals, Leuven

13353

Charité, Berlin

30625

Hannover Medical School, Hanover

53127

Deutsches Zentrum für Neurodegenerative Erkrankungen e.V. (DZNE), Bonn

89081

Ulm University Hospital, Ulm

92037

UC San Diego, ACTRI, La Jolla

AB T6G 1Z1

ALS clinic at the Kaye Edmonton Clinic, University of Alberta, Edmonton

ON N6A 5W9

London Health Sciences Centre - Victoria Hospital, London

M4N 3M5

ALS Research Sunnybrook Health Sciences Centre, Toronto

H3A 2B4

Montreal Neurological Institute and Hospital / Dr Genge, Montreal

04763

Hanyang University Medical Center, Seoul

113 61

Studieenheten Akademiskt specialistcentrum, SLSO, Stockholm

SE- 901 85

Norrlands universitetssjukhus/ University Hospital of Northern Sweden (NUS), Umeå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AL-S Pharma

INDUSTRY

NCT05039099 - A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS) | Biotech Hunter | Biotech Hunter