A first in human study of DNL593 in healthy volunteers & FTD patients
Research type
Research Study
Full title
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
IRAS ID
308443
Contact name
Annelize Koch
Contact email
Sponsor organisation
Denali Therapeutics Inc.
Eudract number
2021-005733-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 27 days
Research summary
The purpose of this study is to investigate the study drug DNL593. This study will be split into 3 separate parts: Part A, Part B & Part C.\n\nThe main objectives of the first part of this study (Part A) are as follows:\n- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of DNL593 when it is administered as a single dose on one occasion at different dose strengths \n\n- To investigate the concentration of DNL593 in the blood, how this changes over a period of time and to evaluate whether there are differences in the concentration of DNL593 between different dose strengths of DNL593 \n\n-To investigate the concentration of DNL593 in the fluid surrounding the brain and spinal cord (cerebrospinal fluid - CSF), and to evaluate whether there are differences in the concentration between different dose strengths of DNL593\n\nThis is a first-in-human study of DNL593. Part A will be conducted in up to 64 healthy volunteers. Details of Parts B & C of the study will be added prior to the commencement of these study parts. The purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in the development of the study drug DNL593.\n
REC name
Wales REC 1
REC reference
21/WA/0383
Date of REC Opinion
8 Dec 2021
REC opinion
Favourable Opinion