DNL593 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
127Frontotemporal lobar degeneration2

127. Frontotemporal lobar degeneration


Clinical trials : 90 Drugs : 87 - (DrugBank : 30) / Drug target genes : 39 - Drug target pathways : 88
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1EUCTR2021-005733-16-ES
(EUCTR)
19/07/202212/05/2022A 3 Part first-in-human study of DNL593 in healthy volunteers and patients with frontotemporal dementia (FTD)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 - Part B, C of first in human study of DNL593 in healthy volunteers & FTD patients Frontotemporal Dementia (FTD)
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DNL593 Sterile Lyophilisate
Product Code: DNL593
INN or Proposed INN: N/A
Other descriptive name: DNL593
Denali Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 1;Phase 2United States;Portugal;Serbia;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Argentina;Brazil;Belgium;Netherlands;Sweden
2NCT05262023
(ClinicalTrials.gov)
February 1, 20221/2/2022A 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 ExtensionFrontotemporal DementiaDrug: DNL593;Drug: PlaceboDenali Therapeutics Inc.TakedaRecruiting18 Years80 YearsAll106Phase 1/Phase 2Netherlands;Spain;Turkey;United Kingdom