A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

Phase 1 Completed 47 enrolled Denali Therapeutics Inc. Takeda · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2022-07-14
Primary completion: 2023-06-08
Completion: 2023-06-08

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DNL919	Unknown	—	—

Indications

No indication recorded.