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DNL201

Phase 1

Healthy Volunteers | Small molecule | Other |Denali Therapeutics Inc.|Last Updated: Sep 16, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04551534A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy VolunteersPHASE1 COMPLETED 122 — — Jun 1, 2017Aug 8, 2018Sep 16, 20201 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs
Up to 20 days
PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma
Up to 10 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma
Up to 10 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only)
Up to 10 days
PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma
Up to 10 days
PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL201 in plasma (multiple dosing only)
Up to 10 days
PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma
Up to 10 days
Secondary Endpoints
Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses)
Up to 10 days
The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935
Up to 10 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DNL201EXPERIMENTALPart 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)
PlaceboPLACEBO_COMPARATORPart 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days)
Interventions
NameTypeDescription
DNL201DRUGOral dose(s)
PlaceboDRUGOral dose(s)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Body mass index 18.5 to 35.0 kg/m², inclusive, and body weight of at least 50.0 kg at screening * In good health, determined by no clinically significant findings from medical history, physical examination, and vital sign measurements * Women of non-childbearing potential ...

Countries:United States
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