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DNL919

Phase 1

Healthy Participant | Small molecule | Other |Denali Therapeutics Inc.|Last Updated: Aug 16, 2023

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05450549A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy ParticipantsPHASE1 COMPLETED 47Jul 14, 2022Jun 8, 2023Aug 16, 20231 Netherlands
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Study Endpoints
Primary Endpoints
Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Up to 45 days
Secondary Endpoints
PK Parameter: Maximum concentration (Cmax) of DNL919 in serum
Up to 45 days
PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf)
Up to 45 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DNL919 (Healthy Participant)EXPERIMENTAL -
Placebo (Healthy Participant)PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DNL919DRUGSingle doses
PlaceboDRUGSingle doses
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive * BMI 18.5 to \<30 kg/m² * When engaging in sex with a woman of child bearing potential, both the male participant and his fema...

Countries:Netherlands
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