ClinicaliQ Trial Snapshot
- A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer’s Disease — Recruiting • Phase I • Neurology • NCT07758595.
- Drug being tested: DNL921 is a novel investigational agent undergoing Phase 1/1b evaluation for safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and patients with Alzheimer's disease through single and multiple ascending dose regimens.
- Patient eligibility overview: The study enrolls two populations—healthy participants without cognitive impairment and patients with confirmed Alzheimer's disease—with participants randomised to receive either DNL921 or placebo in a blinded, controlled design.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.