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

February 3, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. The subject should be a voluntary participant who has understood and signed the ICF.
  2. Age ≥ 18 years and ≤ 50 years, male (including the boundary values).
  3. Body weight ≥ 55 kilograms (kg), body mass index (BMI) = weight (kg) / height² (m²), with BMI within the range of 18-28 (including the boundary values).
  4. The subject agrees to use reliable contraceptive measures (such as abstinence, sterilization surgery, oral contraceptives, injectable contraceptives like medroxyprogesterone, or subcutaneous contraceptive implants) for themselves and their partner during the study and for 6 months after the trial drug infusion.
  5. No history of diseases, or any past medical history abnormalities are deemed clinically insignificant and judged by the study physician to have no impact on the trial.

Exclusion Criteria:

  1. Individuals with a history or current diagnosis of any clinically significant disease that may interfere with the trial results, including but not limited to disorders of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic systems, or those with clinically significant allergic reactions or allergic predisposition, angioedema, interstitial pneumonia, or acute respiratory distress syndrome.
  2. Individuals with acute, chronic, or potential infectious diseases within 1 month prior to dosing.
  3. Individuals with known immune system disorders (autoimmune diseases or immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia.
  4. Individuals with ocular diseases, including a history of intraocular surgery or laser eye surgery.
  5. Individuals with a history of localized cutaneous herpes zoster within 6 months prior to dosing.
  6. Individuals with disseminated cutaneous herpes zoster or herpes zoster involving the central nervous system, either currently or historically.
  7. Individuals with a positive blood group antibody screening (indirect antiglobulin test).
  8. Individuals who have used monoclonal antibodies, cell therapies, or similar treatments within 6 months prior to dosing, or have previously received daratumumab or its analogues, or drugs targeting CD38.
  9. Individuals who have taken any medications (except premedication for QL2109 injection/DARZALEX®) within 2 weeks prior to dosing, including prescription drugs, over-the-counter drugs, and herbal medicines.
  10. Individuals with a history of drug or food allergies, including allergies to any drug or excipient used in the clinical trial.
  11. Individuals with a history of needle or blood phobia, or difficulty with venous blood collection (e.g., history of difficult blood draws or symptoms/signs indicating intolerance to venipuncture).
  12. Individuals who have donated blood or experienced blood loss totaling 200 mL or more within 3 months prior to dosing.
  13. Individuals who have participated in any other drug or medical device clinical trials within 3 months prior to dosing (or within 5 half-lives of the investigational drug if the half-life exceeds 3 months).
  14. Individuals who have undergone major surgery within 3 months prior to signing the informed consent form (ICF).
  15. Individuals who are positive for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis B core antibody (HBcAb); positive for hepatitis C virus antibody (HCV); positive for Treponema pallidum antibody; or positive for human immunodeficiency virus (HIV) antibody.
  16. Individuals with a history of drug abuse or substance dependence, or those with a positive urine drug screen.
  17. Individuals who have received live attenuated or live virus vaccines (e.g., Bacille Calmette-Guérin [BCG]) or viral vector vaccines within 12 months prior to the first dose, or plan to receive such vaccines within 12 months after dosing.
  18. Individuals who have received other vaccines, such as inactivated vaccines or recombinant subunit vaccines, within 1 month prior to the first dose, excluding the aforementioned live attenuated or live virus vaccines and viral vector vaccines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QL2109
Drug: QL2109
Recombinant anti-CD38 fully human monoclonal antibody.
Active Comparator: Darzalex
Drug: Darzalex
Daratumumab injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-∞
Time Frame: Up to Day 71
Area under the serum concentration-time curve from time 0 to infinity
Up to Day 71

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL2109-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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