Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT01477567
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2011-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A First-in-Human Study of LY3009385 in Healthy Participants
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-10
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 determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.
Detailed Description:
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.
Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.
The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.
Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.
The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| I5O-FW-GTCA | OTHER | Eli Lilly and Company | View |