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

NCT06371534 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

  • Tumor

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)

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-12
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371534 on ClinicalTrials.gov