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RECRUITING
NCT06371534
PHASE1

A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2024-04-12

Completion Date

2025-04

Last Updated

2025-02-11

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

QL2109

subcutaneous injection 3-5 min D1 (Day 1, single dose)

DRUG

DARZALEX FASPRO®

subcutaneous injection 3-5 min D1 (Day 1, single dose)

Locations (2)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China