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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

NCT05262023 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-01-15

No results posted yet for this study

Summary

This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period.

Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.

Conditions

  • Frontotemporal Dementia

Interventions

DRUG

DNL593

Ascending single doses (for healthy participants) and multiple doses (for participants with FTD)

DRUG

Placebo

Ascending single doses (for healthy participants) and multiple doses (for participants with FTD)

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Denali Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Amy Berger, MD · Denali Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-12-31
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Colombia
  • Czechia
  • France
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

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 NCT05262023 on ClinicalTrials.gov