A 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05450549

Enrollment

Registered

2022-07-08

Start date

2022-07-14

Completion date

2023-06-08

Last updated

2023-08-16

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

Conditions

Healthy Participant

Brief summary

This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL919.

Detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Interventions

DRUGDNL919

Single doses

DRUGPlacebo

Single doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Female participants of non-childbearing potential (surgically sterilized or post menopausal) or male participants, aged 18 to 55 years, inclusive * BMI 18.5 to \<30 kg/m² * When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception Key

Exclusion criteria

* History of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders * History of malignancy * History of clinically significant stroke * History of cognitive impairment * Positive serum pregnancy test at screening, positive urine pregnancy test at baseline visit, or currently lactating or breastfeeding

Design outcomes

Primary

Measure	Time frame
Safety: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)	Up to 45 days

Secondary

Measure	Time frame
PK Parameter: Maximum concentration (Cmax) of DNL919 in serum	Up to 45 days
PK Parameter: Area under the concentration-time curve from time zero to infinity (AUCinf)	Up to 45 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026