A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants
2 other identifiers
interventional
47
1 country
1
Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2023
CompletedAugust 16, 2023
August 1, 2023
11 months
July 5, 2022
August 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
Up to 45 days
Secondary Outcomes (2)
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
Study Arms (2)
DNL919 (Healthy Participant)
EXPERIMENTALPlacebo (Healthy Participant)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 female partner must use highly effective contraception
You may not qualify if:
- History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
- History of malignancy
- History of clinically significant stroke
- History of cognitive impairment
- Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Denali Therapeutics Inc.lead
- Takedacollaborator
Study Sites (1)
Centre for Human Drug Research (CHDR)
Leiden, South Holland, 2333, Netherlands
Related Publications (1)
Shao Q, Chen S, Zheng Y, Xu W, Chen J, Shao W, Wang Q, Li C, Wang X. Crucial role of microglia-mediated myelin sheath damage in vascular dementia: Antecedents and consequences. Neural Regen Res. 2026 Mar 1;21(3):1000-1012. doi: 10.4103/NRR.NRR-D-24-01109. Epub 2025 Mar 25.
PMID: 40145953DERIVED
Study Officials
- STUDY DIRECTOR
Ana-Claire Meyer, MD
Denali Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 8, 2022
Study Start
July 14, 2022
Primary Completion
June 8, 2023
Study Completion
June 8, 2023
Last Updated
August 16, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share