Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02146625
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2014-05-19
Brief Title:
Safety Tolerability PK PD ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
Sponsor:
HK innoN Corporation
Organization:
HK innoN Corporation
Study Overview
Official Title:
A Dose-block Randomized Single-blind Placebo-controlled Single-dosing Dose-escalation Phase I Clinical Trial to Investigate the SafetyTolerability and PharmacokineticsPharmacodynamics of CJ-40002 After Subcutaneous Injection in Healthy Adult Male Volunteers
Status:
COMPLETED
Status Verified Date:
2016-12
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:
hGH
Brief Summary:
The objectives of this study are
To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers
To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None