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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Aug 2023

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At a glance

  • Drugs DNL 919 (Primary)
  • Indications Alzheimer's disease
  • Focus Adverse reactions
  • Sponsors Denali Therapeutics Inc

Most Recent Events

  • 14 Aug 2023 Status changed from recruiting to completed.
  • 08 Aug 2023 According to a Denali Therapeutics Inc media release, results presented at the Denali Therapeutics Inc media release.
  • 08 Aug 2023 According to a Denali Therapeutics Inc media release, the companies will discontinue clinical development of DNL919 in Alzheimer's disease based on the totality of clinical data emerging from the single ascending dose Phase 1 study of DNL919 in healthy volunteers and in consideration of the rapidly evolving treatment landscape for Alzheimer's disease whereby an understanding of drug combinations with newly approved therapies will be important.

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