Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135363
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-04
Brief Title:
Safety Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects
Sponsor:
Guangzhou JOYO Pharma Co Ltd
Organization:
Guangzhou JOYO Pharma Co Ltd
Study Overview
Official Title:
A Single-center Open Label Study to Evaluate the SafetyTolerability and Pharmacokinetics of Multiple Administration of Sufenidone SC1011 Tablets in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2023-10
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 goal of this clinical trial is to learn about the safety tolerability and pharmacokinetic profiles of SC1011 in healthy conditions The main questions it aims to answer are Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects Participants will complete the study including screening period dosing period and observation period Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkerseg blood TNFα to see if they are different between the two drugs
Detailed Description:
This is a single-center open label study to evaluate the safetytolerability and pharmacokinetics of multiple administration of Sufenidone SC1011 tablets conducted in 2 groups
Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1 twice daily on days 2-6 and once within half an hour after breakfast on day 7
Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days with dosing consisting of one dose within half an hour after breakfast on day 1 twice daily on days 2-6 and once within half an hour after breakfast on day 7
Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1 twice daily on days 2-6 and once within half an hour after breakfast on day 7
Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days with dosing consisting of one dose within half an hour after breakfast on day 1 twice daily on days 2-6 and once within half an hour after breakfast on day 7
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