NCT05924243

A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.

A Phase 1b, Adaptive, Multi-Center, Randomized, Double Blind, Placebo-Controlled, Parallel Design Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H\&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	RO7486967	For up to approximately 28 days
DRUG	Placebo	For up to approximately 28 days

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2023-06-29
• Last updated: 2024-09-19

Locations

17 sites across 3 countries: United States, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study