Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 9:00 PM
Study NCT ID:
NCT05369858
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Mass Balance and Biotransformation Study of [14C]SKLB1028 in Chinese Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2022-05
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 single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] SKLB1028.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: