Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjec

Status: 
Recruiting
Clinicaltrials.gov identifier: 
NCT03611569
Sponsor: 
H. Lundbeck A/S
Enrollment: 
44
Study Design: 
Single ascending dose study. Cohort A: A1, A2, and A3: 24 healthy subjects in active arm and in placebo, with 8 subjects per cohort per treatment arm (aiming for an equal number of men and women). Cohort A4: 12 healthy subjects per treatment arm, with 6 non-Japanese subjects and 6 Japanese subjects (aiming for an equal number of men and women). Part B: Cohort B1: 8 patients with PD in active arm: 8 in placebo.
Rationale: 
PRIMARY OUTCOME MEASURE: Adverse events. SECONDARY OUTCOME MEASURES: spectrum of pharmacokinetic and pharmacodynamic measures including free/total α-synuclein concentration in cerebrospinal fluid and plasma. Antidrug antibodies in serum will be measured as well.
Comments: 
This is an early phase Single Ascending Dose (SAD) study that will define viability of the molecule to move into the more advanced stages of the development. MEDI1341 is an α-synuclein antibody that is potentially differentiated by its high affinity, high selectivity and reduced effector function (lower interaction with the immune system). The impact of this differential profile will be determined in future studies.