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RO7486967

Phase 1

Parkinson Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

RO7486967 · 1 trial · 1 indication

Phase 1 1
NCT05924243A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.Parkinson Disease
COMPLETED60 Analytics
PHASE1COMPLETED
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with adverse events (AEs)
Up to 45 Days
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline
From Baseline to Up to 45 Days

Secondary Endpoints

Time to maximum concentration of RO7486967 in Plasma
Day 1, Day 15, and Day 28
Maximum concentration (Cmax) of RO7486967 in Plasma
Day 1, Day 15, and Day 28
Area under the curve (AUC) RO7486967 in Plasma
Day 1, Day 15, and Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7486967 ArmEXPERIMENTALParticipants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.
PlaceboPLACEBO_COMPARATORMatching placebo

Interventions

NameTypeDescription
RO7486967DRUGFor up to approximately 28 days
PlaceboDRUGFor up to approximately 28 days
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Key Criteria: * Male or post-menopausal female * Diagnosis of clinically probable idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) * A time from diagnosis of PD of at least 3 to maximum 60 months (5 years) at scree...

Countries:United StatesNetherlandsUnited Kingdom
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Frequently asked questions about RO7486967

What is RO7486967 used for in Parkinson Disease?

RO7486967 is an investigational small molecule being studied for the treatment of early idiopathic Parkinson's Disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its safety, tolerability, pharmacokinetics, and pharmacodynamics in affected patients.

Who makes RO7486967?

RO7486967 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical research to evaluate this investigational drug for Parkinson's Disease.

What phase is RO7486967 in?

RO7486967 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for Parkinson's Disease.

What clinical trials is RO7486967 in?

RO7486967 has one completed Phase 1 clinical trial registered under NCT05924243. This study investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in 60 participants with early idiopathic Parkinson's Disease. The trial was conducted in the United States, Netherlands, and United Kingdom.

How does RO7486967 work?

RO7486967 is a small molecule therapeutic being developed for Parkinson's Disease. The specific molecular target and mechanism of action have not been disclosed in available clinical trial information. The drug is being evaluated for its effects on the disease through ongoing clinical research.