Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Single-ascending Dose Study of Kylo-11 in Healthy Subjects
Sponsor:
Kylonova Xiamen Biopharma co LTD
Organization:
Kylonova Xiamen Biopharma co LTD
Study Overview
Official Title:
A Phase 1 Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 first-in-human randomized double-blind placebo-controlled single ascending dose study in healthy volunteers Kylo-11 will be evaluated in approximately 60 subjects to assess safety tolerability pharmacokinetics and pharmacodynamic effects
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?:
None
Is an FDA AA801 Violation?:
None