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NOT YET RECRUITING
NCT07400744
PHASE1

A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects.

Official title: Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity (Randomized, Double-blind, Single Dose, Parallel Controlled) of QL2109 With Daratumumab Injection in Healthy Chinese Male Subjects

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-03

Completion Date

2026-10

Last Updated

2026-02-10

Healthy Volunteers

Yes

Interventions

DRUG

QL2109

Recombinant anti-CD38 fully human monoclonal antibody.

DRUG

Darzalex

Daratumumab injection