NCT04449484

Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study of multiple ascending iv doses of MEDI341 in male and female subjects with Parkinson's Disease.

Detailed description

The study will include up to 3 cohorts, with 12 subjects in each, for a total of up to 36 randomised subjects. The study comprises a screening period of up to 49 days, an 8-week double-blind treatment period, and a 13-week follow-up period. Each subject will receive three 60 minute iv infusions of MEDI1341 or placebo during the 8-week treatment period, with 4 weeks between infusions. The overall study duration (enrolment, treatment, and follow-up periods) will be up to 28 weeks per subject. A Dose Escalation Committee will review data from each cohort to allow progression to the next higher dose cohort in the study.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	MEDI1341	Intravenous infusion over 60 minutes
OTHER	Placebo	Intravenous infusion over 60 minutes

Timeline

• Start date: 2020-08-04
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2020-06-26
• Last updated: 2022-06-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study