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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06371534
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date April 2024
Completion date April 2025

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