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

Sponsor
Denali Therapeutics Inc.
Study ID
NCT07758595
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • DNL921 — DRUG
    Single or multiple doses
  • Placebo — DRUG
    Single or multiple doses matched to experimental treatment

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Aug 7, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
  • Placebo Comparator: Placebo Arm

Primary Outcome Measure

Part A: Incidence and severity of treatment-emergent averse events (TEAEs) [ Time Frame: 46 days ]

Central Contacts

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