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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

NCT05450549 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2023-08-16

No results posted yet for this study

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.

Conditions

  • Healthy Participant

Interventions

DRUG

DNL919

Single doses

DRUG

Placebo

Single doses

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Denali Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Ana-Claire Meyer, MD · Denali Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2023-06-08
Completion
2023-06-08

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450549 on ClinicalTrials.gov