Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-25 @ 2:25 AM
NCT ID:
NCT06371534
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.
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.
Study:
NCT06371534
Study Brief:
Protocol Section:
NCT06371534