Recent Updates
Recently added Catalysts

DNL919

Phase 1

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

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical trial landscape

DNL919 · 1 trial · 1 indication

Phase 1 1
NCT05450549A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy ParticipantsHealthy Participant
COMPLETED47 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
Healthy Participant
NCT0545054947
Unlock trial analytics
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 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
Unlock Eligibility Criteria