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DNL151

Phase 1

Healthy Volunteers | Small molecule | Other |Denali Therapeutics Inc.|Last Updated: Mar 7, 2022

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 Enrollment186
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04557800A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy VolunteersPHASE1 COMPLETED 186 — — Nov 16, 2017Feb 19, 2021Mar 7, 20222 Netherlands
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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 42 days
PK parameter: Maximum observed concentration (Cmax) of DNL151 in plasma
Up to 42 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL151 in plasma
Up to 42 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL151 in plasma (single dosing only)
Up to 42 days
PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL151 in plasma
Up to 42 days
PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-τ) of DNL151 in plasma (multiple dosing only)
Up to 42 days
PK parameter: Apparent terminal elimination half-life (t1/2) of DNL151 in plasma
Up to 42 days
Secondary Endpoints
Concentration of DNL151 in cerebrospinal fluid (CSF) (following selected single and multiple doses)
Up to 13 days
The pharmacodynamics of DNL151 in whole blood as measured by the percent change from baseline in pS935
Up to 42 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DNL151EXPERIMENTALPart A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days); Part C: Single-dose cohort; Part D: Additional multiple-dose cohort (28 days); Part E Multiple-ascending dose cohorts (14 days)
PlaceboPLACEBO_COMPARATORPart A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days); Part C: Single-dose cohort; Part D: Additional multiple-dose cohort (28 days); Part E Multiple-ascending dose cohorts (14 days)
Interventions
NameTypeDescription
DNL151DRUGoral dose(s)
PlaceboDRUGoral dose(s)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

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:Netherlands
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