Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 60 patients with Parkinson's disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prothena Biosciences Limited
• Collaborator: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Idiopathic Parkinson's disease, Hoehn and Yahr 1-3

• Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs

• Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception

• Male subjects and their partners of childbearing potential must use contraception

Exclusion Criteria:

• Significant cardiac history

• Abnormal MRI

• Significant laboratory abnormalities