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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDenali Therapeutics Inc.

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Are male or female of non-childbearing potential and aged 50 to 75 years at the time of screening

Trial design

Treatments tested in this trial

  • DNL921
  • Placebo

Treatment groups

178 Participants
are divided into 2 treatment groups

Sponsors and collaborators