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Study to Evaluate DNL151 in Subjects With Parkinson's Disease

Study to Evaluate DNL151 in Subjects With Parkinson's Disease

Recruiting
30-75 years
All
Phase 1

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL151 in subjects with Parkinson's disease.

Description

 

Eligibility

Inclusion Criteria:
  • Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive
  • Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H&Y Stage I, II, or III.
  • Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific study assessments
Exclusion Criteria:
  • Any history of clinically significant asthma, chronic obstructive pulmonary disease, or emphysema within 5 years of screening, or other clinically significant pulmonary disease within 6 months of screening
  • Abnormal Vitals including Respiratory Rate, Body Temperature, Blood Pressure, and Pulse Rate
  • Pulmonary Function Tests (PFTs) (FVC <60% predicted, FEV1 <50% predicted, FEV1:FVC ratio <0.6, DLCO <70% predicted)
  • Clinically significant neurologic disorder other than Parkinson's disease, including history of stroke within 12 months of screening, cognitive impairment, seizure within 5 years of screening, or head trauma with loss of consciousness within 6 months of screening
  • Montreal Cognitive Assessment (MoCA) score of <24 at screening

Study details
    Parkinson's Disease
    Parkinson's Disease

NCT04056689

Denali Therapeutics Inc.

19 February 2024

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