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Clinical Trial ยท PHASE1 ยท Recruiting

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

07 September 2026 NCT07758595 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE1
Participants
ALL
Age Range
18 Years โ€“ 75 Years

About This Trial

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.

Who Can Join?

Key Inclusion Criteria (Healthy Participants): * Are male or female of non-childbearing potential and are aged 18 through 60 years at the time of screening * Have a BMI of 18 through 32 kg/m2 and a body weight of at least 50 kg * For female participants: Are of non-childbearing potential * For male participants: Are surgically sterile by bilateral orchidectomy, or are abstinent, or agree to use two acceptable forms of contraception Key Exclusion Criteria (Healthy Participants): * Have any history of clinically significant neurological, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematological, immunological, or allergic disease, or other major disorders * Have a positive serum pregnancy test or are currently lactating or breastfeeding * Have been hospitalized during the 4 weeks prior to screening Key Inclusion Criteria (Participants with AD): * Are male or female of non-childbearing potential and aged 50 to 75 years at the…

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