Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427590
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-10
Brief Title:
Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects
Sponsor:
Gannex Pharma Co Ltd
Organization:
Gannex Pharma Co Ltd
Study Overview
Official Title:
A Phase I Randomized Double-Blind Placebo-Controlled Single Dose Escalation Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-09
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 will be a phase I randomized double-blind placebo-controlled single-dose escalation study This study will be conducted in three periods the screening period the treatment period and the follow-up period
This study aims to evaluate the pharmacokinetics target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects
This study aims to evaluate the pharmacokinetics target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects
Detailed Description:
The study will consist of five cohorts each with different doses of ASC47 Cohorts 1 and 2 have 6 subjects of which 4 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo Cohorts 3 4 and 5 have 8 subjects of which 6 subjects will receive the single dose of ASC47 and 2 subjects will receive matching 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?:
False
Is an FDA AA801 Violation?:
None