Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918588
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-06-15
Brief Title:
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects
Sponsor:
Kadmon a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 1 Placebo-Controlled Double-Blind Dose-Escalating Study to Examine the Safety and Tolerability of Multiple Doses of KD025 Formerly Called SLX-2119 in Healthy Male and Post- Menopausal Female Subjects
Status:
COMPLETED
Status Verified Date:
2023-06
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 purpose of this study is to determine the safety tolerability and pharmacokinetics of multiple oral doses and regimens of KD025 in healthy male and post-menopausal female participants
Detailed Description:
Up to approximately 37 days including safety follow up period of 30 days after participant is treated with the last dose of study drug
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1290-9646 | REGISTRY | ICTRP | None |