Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395012
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-29
Brief Title:
A First-In-Human Study of LY3985297 in Healthy Participants
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 1 Randomized Placebo-controlled Investigator and Participant Blinded Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety Tolerability and Pharmacokinetics of LY3985297 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-09
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 see if LY3985297 the study drug is safe and well-tolerated when given as a single dose or as multiple doses either through an intravenous into a vein or a subcutaneous under the skin injection in healthy participants Study will also evaluate how much of the study drug LY3985297 gets into the blood stream and how long it takes the body to remove it
The study is conducted in two parts part A and B each part has a separate treatment cohort
The study will last up to approximately 116 days for part A and 145 days for part B including the screening period
The study is conducted in two parts part A and B each part has a separate treatment cohort
The study will last up to approximately 116 days for part A and 145 days for part B including the screening period
Detailed Description:
None
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 |
|---|---|---|---|
| J4S-MC-KSAA | OTHER | Eli Lilly and Company | None |