Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490263
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-18
Brief Title:
the Safety Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids in Human
Sponsor:
Beijing Wehand-Bio Pharmaceutical Co Ltd
Organization:
Beijing Wehand-Bio Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Clinical Trial in Healthy and OverweightObese Subjects to Investigate the Safety Tolerability and Pharmacokinetics of Mulberry Twig Alkaloids
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This trial is conducted in China The aim of the trial is to investigate safety tolerability and pharmacokinetics of the Mulberry Twig Alkaloids tablets WH006 in healthy overweight and obesity subjects
Detailed Description:
This is a Phase I clinical trial of safety tolerability and pharmacokinetics of the Mulberry Twig Alkaloids tablets WH006 in healthy and overweight or obesity subjects This trial is divided into three parts
The first part study aims to compare the pharmacokinetics characteristics of WH006 chewing with the first bite of a standardized meal or swallowing after a standardized meal in healthy subjects
The second part study aims to investigate the safety tolerability and pharmacokinetics of single ascending doses of WH006 in healthy subjects
The third part study aims to investigate the safety tolerability and pharmacokinetics of multiple ascending doses of WH006 in both healthy participants and overweight or obese subjects
The first part study aims to compare the pharmacokinetics characteristics of WH006 chewing with the first bite of a standardized meal or swallowing after a standardized meal in healthy subjects
The second part study aims to investigate the safety tolerability and pharmacokinetics of single ascending doses of WH006 in healthy subjects
The third part study aims to investigate the safety tolerability and pharmacokinetics of multiple ascending doses of WH006 in both healthy participants and overweight or obese subjects
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