Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06328400
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-03-18
Brief Title:
A Study to Evaluate the Safety Tolerability and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension
Sponsor:
Vigonvita Life Sciences
Organization:
Vigonvita Life Sciences
Study Overview
Official Title:
A Multiple-dose Randomized Double-blind Placebo-controlled Phase I Clinical Study to Evaluate the Safety Tolerability and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension in Chinese Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-02
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 a multi dose randomized double-blind placebo-controlled single center Phase I clinical study The purpose of this study is to evaluate the safety tolerability and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers
Detailed Description:
Two groups are initially set up starting from Group 1 and progressing sequentially to Group 2 After all volunteers in the first group 900 mg BID group complete the safety follow-up on the 4th day after the last dose ie D10 the safety information and PK data will be reviewed jointly by the researchers and sponsors before the second group of volunteers starting administration The preferred dose for the second group is 900 mg TID and if there are safety risks found after the Group 1 study it will be adjusted to 1200 mg BID or other appropriate dosage and frequency
A total of 24 volunteers are planned to be enrolled with 12 volunteers in each group The trial drug and placebo will be allocated in a 31 ratio with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo
A total of 24 volunteers are planned to be enrolled with 12 volunteers in each group The trial drug and placebo will be allocated in a 31 ratio with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo
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