A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants - FIH of DNL919 in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51440

Enrollment

Registered

2022-06-08

Start date

2022-07-24

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers Alzheimer's Disease

Interventions

DNL919 or placebo

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy male participants and healthy female participants of non childbearing potential aged between 18 and 55 years, inclusive, with a body mass index (BMI) between 18.5 and 32 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Women of childbearing potential will be excluded in this study because reproductive toxicity studies have not yet been performed. Also, participants with any history of clinically significant neurological, psychiatric, endocrine (including diabetes mellitus), pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders.

Design outcomes

Primary

Measure	Time frame
Incidence, severity, and seriousness of treatment-emergent adverse event (TEAEs)	—

Secondary

Measure	Time frame
• DNL919 serum PK parameters following single IV doses of DNL919, including but not limited to: o maximum concentration (Cmax) o area under the concentration-time curve from time zero to infinity (AUCinf)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)