Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:50 AM
Study NCT ID:
NCT04234594
Status:
UNKNOWN
Last Update Posted:
2020-05-19
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Males.
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind and Single-dose Study to Compare the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Male Subjects.
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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:
A randomized, double-blind and parallel group study to compare the pharmacokinetic and safety of QL1203 and Vectibix® in healthy males.
Detailed Description:
This is a phase I,single center, randomized, double-blind，single-dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of of QL1203 or Vectibix® in healthy male volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of QL1203 or Vectibix® in healthy male volunteers".
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?: