Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05262023
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2022-02-01
Brief Title:
A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia FTD-GRN
Sponsor:
Denali Therapeutics Inc
Organization:
Denali Therapeutics Inc
Study Overview
Official Title:
A Phase 12 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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 12 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005733-16 | EUDRACT_NUMBER | None | None |