A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers

Status: 
Recruiting
Clinicaltrials.gov identifier: 
NCT03272165
Sponsor: 
AstraZeneca
Enrollment: 
48
Study Design: 
This is a single-center study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 80 years. The study will include up to 5 planned cohorts; each cohort will comprise 8 subjects. An optional sixth cohort of 8 subjects may be studied. Each subject will receive a single 60-minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks. The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in Healthy Volunteers.
Rationale: 
PRIMARY OUTCOME MEASURE: Adverse events. SECONDARY OUTCOME MEASURES: spectrum of pharmacokinetic and pharmacodynamics 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.