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)

Amyotrophic Lateral Sclerosis (ALS)

(Double-blind Phase): Incidence of AEs and SAEs including immunogenicity., (Double-blind Phase): Incidence of abnormalities in vital signs, clinical laboratory assessments, physical and neurological examinations, electrocardiograms and changes in weight., (Open-label Extension): Incidence of AEs and SAEs including immunogenicity., (Open-label Extension): Incidence of abnormalities in vital signs, clinical laboratory assessments, physical and neurological examinations, electrocardiograms and changes in weight.

(Double-blind Phase): The primary PK parameters are AUC, concentration at the end of infusion and t1/2, (Double-blind Phase): AP-101 levels in the CSF, (Double-blind Phase): Measurement of pNfH and NfL levels in the CSF and plasma after multiple IV doses of AP-101, (Open-label Extension): The primary PK parameters are AUC, concentration at end of infusion and t1/2, (Open-label Extension): Measurement of pNfH and NfL levels in CSF and plasma after multiple IV doses of AP-101

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