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DNL151

Phase 1

Parkinson's Disease | Small molecule | Neurology |Biogen Inc.|Last Updated: Apr 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

DNL151 · 1 trial · 1 indication

Phase 1 1
NCT04056689Study to Evaluate DNL151 in Subjects With Parkinson's DiseaseParkinson's Disease
COMPLETED36 Analytics
PHASE1COMPLETED
Study to Evaluate DNL151 in Subjects With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Randomization to Day 42
Number of Subjects with laboratory test abnormalities
Randomization to Day 42
Number of Subjects with vital sign abnormalities
Randomization to Day 42
Number of Subjects with electrocardiogram (ECG) abnormalities
Randomization to Day 42
Number of Subjects with clinically significant neurological examination abnormalities
Randomization to Day 42

Secondary Endpoints

Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151
Randomization to Day 28
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151
Randomization to Day 28
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151
Randomization to Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DNL151 Low DoseEXPERIMENTAL -
DNL151 Mid DoseEXPERIMENTAL -
DNL151 High DoseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DNL151DRUGOral repeating dose
PlaceboDRUGOral repeating dose
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Eligibility Criteria

Age Range30 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Key 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 Key E...

Countries:United StatesBelgiumNetherlandsUnited Kingdom
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Frequently asked questions about DNL151

What is DNL151 used for in Parkinson's Disease?

DNL151 is an investigational small molecule being studied for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. A completed Phase 1 trial evaluated its safety and tolerability in patients with Parkinson's Disease.

Who makes DNL151?

DNL151 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research to evaluate the drug's potential as a treatment for Parkinson's Disease.

What phase is DNL151 in?

DNL151 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is still undergoing clinical evaluation for Parkinson's Disease.

What clinical trials is DNL151 in?

DNL151 has one completed clinical trial registered as NCT04056689, titled 'Study to Evaluate DNL151 in Subjects With Parkinson's Disease.' This Phase 1 study enrolled 36 participants and was conducted in the United States, Belgium, Netherlands, and United Kingdom.

Is DNL151 FDA approved?

DNL151 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Parkinson's Disease. The drug has completed a Phase 1 trial but has not yet received marketing authorization from regulatory agencies.