Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311656
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-08
Brief Title:
A Study to Evaluate Safety Tolerability of LY4100511 DC-853 in Healthy Asian and Non-Asian Participants
Sponsor:
DICE Therapeutics Inc a wholly owned subsidiary of Eli Lilly and Company
Organization:
DICE Therapeutics Inc a wholly owned subsidiary of Eli Lilly and Company
Study Overview
Official Title:
A Placebo-controlled Phase 1 Participant- and Investigator-blinded Single- and Multiple- Dose Study to Evaluate Safety Tolerability and Pharmacokinetics of LY4100511 DC-853 in Healthy Asian and Non-Asian Participants
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The main purpose of this study is to assess the safety and tolerability of LY4100511 DC-853 after single and multiple dose administrations in healthy asian participants and non-Asian participants Part A consists of 2 groups and Part B C and D include optional groups
Detailed Description:
Part B and C added per protocol amendment May 2024 Added Part B to explore higher dose levels and Part C to explore effects of food Part D added per protocol amendment June 2024 to explore higher multiple doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| J5C-MC-FOAA | OTHER | DICE Therapeutics a wholly owned subsidiary of Eli Lilly and Company | None |