SAD Clinical Trial Testing MEDI1341 in Healthy Volunteers
Research type
Research Study
Full title
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
IRAS ID
269117
Contact name
Ashley Brooks
Contact email
Sponsor organisation
AstraZeneca R&D BioPharmaceuticals Neuroscience
Eudract number
2019-002352-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
MEDI1341 is being developed as a therapeutic antibody for the treatment of patients with Parkinson’s disease (PD) which is a slowly progressive and debilitating disease with age related movement disorder.
The study is a first-in-human and will be conducted as a randomised double blind, placebo controlled study of single ascending intravenous doses of MEDI1341 in male and non-fertile female healthy volunteers aged 18 to 65 years.
The study will include a total of 6 cohorts. Each cohort will compromise 8 healthy to provide 48 randomised volunteers.
Within each cohort 6 volunteers will be randomised to receive MEDI1341 and 2 subjects will be randomised to receive placebo administered by intravenous infusion.
For each cohort, 2 volunteers will be dosed initially, such that 1 volunteer will receive MEDI1341 and 1 subject will receive placebo.
Provided no clinically significant safety issues are noted in the first 72 hours following dosing of the initial 2 subjects, in the Investigator’s opinion and confirmed by all the Medical Monitors, and provided the Day 2 safety laboratory tests have been reviewed, the remaining 6 subjects in the cohort may be dosed.
The randomization ratio for these remaining 6 volunteers will be 5:1 (MEDI1341: placebo).
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0461
Date of REC Opinion
21 Oct 2019
REC opinion
Further Information Favourable Opinion