Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT06371534
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
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:
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 1800mg#15ml# 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 1800mg#15ml# 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?: