Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-14
Brief Title:
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO in Healthy Adults
Sponsor:
Qilu Pharmaceutical Co Ltd
Organization:
Qilu Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Single-dose Parallel Study to Compare the Pharmacokinetics and Safety of QL2109 and DARZALEX FASPRO in Healthy Male Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO in healthy male volunteers
Participants will receive a single injection of QL2109 DARZALEX FASPRO Researchers will compare pharmacokinetic safety and immunogenic similarities between the two groups
Participants will receive a single injection of QL2109 DARZALEX FASPRO Researchers will compare pharmacokinetic safety and immunogenic similarities between the two groups
Detailed Description:
This is a phase I randomized double-blind and parallel group clinical trial The primary objective is to assess the pharmacokinetic similarity of single injections of QL2109 or DARZALEX FASPRO in healthy volunteers
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2109 or DARZALEX FASPRO in healthy volunteers
Subjects would receive a single 1800mg15ml of QL2109 or DARZALEX FASPRO injection
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL2109 or DARZALEX FASPRO in healthy volunteers
Subjects would receive a single 1800mg15ml of QL2109 or DARZALEX FASPRO injection
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