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NOT YET RECRUITING
NCT07758595
PHASE1

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

Sponsor: Denali Therapeutics Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 1/1b, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL921 in healthy participants and participants with Alzheimer's disease (AD). The principal aim of this study is to obtain safety and tolerability data. This information, together with PK and PD data, will inform dose selection and design of future studies.

Official title: A Phase 1/1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Dose and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2026-08

Completion Date

2030-04

Last Updated

2026-08-11

Healthy Volunteers

Yes

Interventions

DRUG

DNL921

Single or multiple doses

DRUG

Placebo

Single or multiple doses matched to experimental treatment