Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05493631
Status:
RECRUITING
Last Update Posted:
2022-08-25
First Post:
2022-07-21
Brief Title:
A Phase 1b Study to Assess the Safety Tolerability PK and PD of MG1113 in Hemophilia Patient
Sponsor:
GC Biopharma Corp
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Phase 1b Multiple Ascending Dose Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Subcutaneous MG1113 in Patients With Severe Hemophilia
Status:
RECRUITING
Status Verified Date:
2022-08
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 purpose of this study is to assess the safety and tolerability pharmacokinetics and pharmacodynamics of subcutaneous MG1113 in the multiple ascending dose study in patients with severe hemophilia
Detailed Description:
This is a repeat-dose study that assign 5 subjects in each cohort to explore the safety tolerability PK and PD of the study drug by sequentially increasing the study drug
The route of administration is subcutaneous SC injection Dose escalation will be decided after checking the safety and tolerability at the previous dose to the extent not exceeding the criteria for discontinuation of dose escalation The dose escalation will be decided by the Steering Committee and Data and Safety Monitoring Boards DSMB in the evaluation of the safety and tolerability data obtained from each cohort after repeated administration of MG1113
The subjects will be treated with 20 mgkg once weekly for 8 weeks in cohort 1 Visit window of 1 day calculated from Day1 are allowed for the dosing schedule after first IP administration Day 1 But next scheduled IP administration must be kept in mind to ensure subjects will not have more than 8 days in between IP dosing interval
The next dose level Dose A and B will be determined based on the safety PK and PD data obtained from previous dose level If a criterion of discontinuation of dose escalation is fulfilled discussion about dose escalation is available for next cohort The dose selection and escalation will be finally determined from the Steering Committee and DSMB The safety tolerability PK and PD data obtained from all subjects up to Cohort 3 will be evaluated by the Steering Committee and Data and Safety Monitoring Boards DSMB
The route of administration is subcutaneous SC injection Dose escalation will be decided after checking the safety and tolerability at the previous dose to the extent not exceeding the criteria for discontinuation of dose escalation The dose escalation will be decided by the Steering Committee and Data and Safety Monitoring Boards DSMB in the evaluation of the safety and tolerability data obtained from each cohort after repeated administration of MG1113
The subjects will be treated with 20 mgkg once weekly for 8 weeks in cohort 1 Visit window of 1 day calculated from Day1 are allowed for the dosing schedule after first IP administration Day 1 But next scheduled IP administration must be kept in mind to ensure subjects will not have more than 8 days in between IP dosing interval
The next dose level Dose A and B will be determined based on the safety PK and PD data obtained from previous dose level If a criterion of discontinuation of dose escalation is fulfilled discussion about dose escalation is available for next cohort The dose selection and escalation will be finally determined from the Steering Committee and DSMB The safety tolerability PK and PD data obtained from all subjects up to Cohort 3 will be evaluated by the Steering Committee and Data and Safety Monitoring Boards DSMB
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