Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365580
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Dose Escalation Study of Kylo-0603 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 Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of Kylo-0603 Capsules in Healthy Subjects
Status:
COMPLETED
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 clinical trial is the first-in-human study of Kylo-0603 The purpose of this randomized double-blind placebo-controlled phase 1 study is to assess the safety tolerability pharmacokinetics pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects
Detailed Description:
The study consists of three parts single ascending doses Part 1 food effect Part 2 and multiple ascending doses Part 3
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