NCT05262023

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

A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Denali Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-12-01
• Completion: 2028-11-01
• First posted: 2022-03-02
• Last updated: 2026-01-15

Locations

26 sites across 12 countries: United States, Belgium, Brazil, Colombia, Czechia, France, Italy, Netherlands, Portugal, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study