Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03855696
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2019-02-12
Brief Title:
A Study to Investigate the Safety Tolerability PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Phase I Randomized Double-blind Placebo-Controlled Single Ascending Dose Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of MG1113 in Healthy Subjects and Hemophilia Patients
Status:
COMPLETED
Status Verified Date:
2021-10
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 purpose of this study is to assess the safety and tolerability of MG1113 in the single ascending dose study IV injection or SC injection in healthy subjects and hemophiia patients
Detailed Description:
This is a single-dose study that explore the safety tolerability PK and PD of the study drug by sequentially increasing the study drug in 4 dose levels The route of administration is either subcutaneous SC injection or intravenous IV injection
For healthy subjects 6 subjects will be assigned to the study group and 2 subjects will be assigned to the placebo group to explore the safety and tolerability and PKPD of the study drug in comparison with placebo Hemophilia patients will be assigned only to the study group with 3 and 6 subjects in each cohort respectively
The investigator and subjects will know which cohort the healthy subjects have been assigned to but they will be double-blinded as to whether the subjects are assigned to the study group study drug or the placebo group placebo within each cohort
The doses planned in healthy subjects are 05 mgkg 17 mgkg and 33 mgkg by SC injection 33 mgkg by IV injection In hemophilia patients 17 mgkg and 33 mgkg will be administered by SC injection The planned dose will be administered 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 Data Monitoring CommitteeDMC and Data and Safety Monitoring Boards DSMB in the blinded evaluation of the safety and tolerability data obtained from each previous cohort for 7 days after administration Before deciding dose escalation and proceeding to the next step the safety tolerability PK and PD data obtained from all healty subjects and hemophilia patients up to cohort 6 will be evaluated by the Data and Safety Monitoring Boards DSMB in an unblinded manner In addition if necessary the analysis result of cohort that has completed all the scheduled visits can be reviewed in an unblinded manner
For healthy subjects 6 subjects will be assigned to the study group and 2 subjects will be assigned to the placebo group to explore the safety and tolerability and PKPD of the study drug in comparison with placebo Hemophilia patients will be assigned only to the study group with 3 and 6 subjects in each cohort respectively
The investigator and subjects will know which cohort the healthy subjects have been assigned to but they will be double-blinded as to whether the subjects are assigned to the study group study drug or the placebo group placebo within each cohort
The doses planned in healthy subjects are 05 mgkg 17 mgkg and 33 mgkg by SC injection 33 mgkg by IV injection In hemophilia patients 17 mgkg and 33 mgkg will be administered by SC injection The planned dose will be administered 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 Data Monitoring CommitteeDMC and Data and Safety Monitoring Boards DSMB in the blinded evaluation of the safety and tolerability data obtained from each previous cohort for 7 days after administration Before deciding dose escalation and proceeding to the next step the safety tolerability PK and PD data obtained from all healty subjects and hemophilia patients up to cohort 6 will be evaluated by the Data and Safety Monitoring Boards DSMB in an unblinded manner In addition if necessary the analysis result of cohort that has completed all the scheduled visits can be reviewed in an unblinded manner
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