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

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508697-28-00

Acronym

DNLI-H-0001

Enrollment

Registered

2024-05-15

Start date

2024-11-13

Completion date

Unknown

Last updated

2025-12-03

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

Conditions

Frontotemporal Dementia (FTD)

Brief summary

Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) [Timeframe: Up to 18 months], Change from baseline in safety laboratory values, vital sign measurements, ECG results, and physical/neurological examination findings [Timeframe: Up to 18 months]

Detailed description

DNL593 serum PK parameters (when feasible): Cmax, tmax, Ctrough, AUClast, AUCt , t 1/2, Accumulation ratio [Timeframe: Up to 18 months], Concentration of DNL593 in cerebrospinal fluid (CSF) [Timeframe: Up to 18 months], DNL593 CSF:serum concentration ratio [Timeframe: Up to 18 months], Percentage change from baseline in plasma Nfl at Week 25

Interventions

DRUG-

DRUGDNL593 Placebo

DRUGSterile lyophilisate in single-dose glass vials

DRUGFAMOTIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) [Timeframe: Up to 18 months], Change from baseline in safety laboratory values, vital sign measurements, ECG results, and physical/neurological examination findings [Timeframe: Up to 18 months]	—

Secondary

Measure	Time frame
DNL593 serum PK parameters (when feasible): Cmax, tmax, Ctrough, AUClast, AUCt , t 1/2, Accumulation ratio [Timeframe: Up to 18 months], Concentration of DNL593 in cerebrospinal fluid (CSF) [Timeframe: Up to 18 months], DNL593 CSF:serum concentration ratio [Timeframe: Up to 18 months], Percentage change from baseline in plasma Nfl at Week 25	—

Countries

Belgium, Czechia, France, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026