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

Launched by QILU PHARMACEUTICAL CO., LTD. · Apr 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare a new drug called QL2109 with an existing medication known as DARZALEX FASPRO® to see how they perform in healthy adult men. The researchers want to understand how each drug is absorbed by the body and how safe they are. If you participate, you will receive a single injection of either QL2109 or DARZALEX FASPRO®, and your health will be monitored to see how your body reacts to the medication.

To be eligible for this study, you must be a healthy male between the ages of 18 and 50, weigh between 65 kg and 90 kg (about 143 to 198 pounds), and have a normal body mass index (BMI). You also need to agree to use effective contraception during the study. However, if you have any serious health conditions, a history of certain infections, or have taken specific medications recently, you may not qualify. If you choose to participate, you can expect close monitoring and support from the research team throughout the study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Sign the informed consent form and fully understand the test content,process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
• • Age 18 \~ 50 (inclusive) years , male;
• • 65.0 kg≤ body weight ≤90.0 kg and 18.0 kg/m2≤ Body mass index (BMI)
• • ≤28.0 kg/m2;
• • Agree to use effective contraception throughout the study period (including but not limited to: physical contraception, surgery, abstinence, etc.) until at least 6 months after the study dosing;
• • No history of disease or abnormal past medical history is not clinically significant, and the study doctor's judgment has no impact on the trial.
• Exclusion Criteria:
• • Have been or are currently suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system,respiratory system, urogenital system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that can interfere with the test results;
• • With acute, chronic, or latent infectious diseases within 1 month before administration;
• • With known immune system diseases (autoimmune diseases and immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia;
• • Has experienced a recent single dermatomal herpes zoster eruption within 6 months before administration;
• • Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) herpes zoster during the screening period or before;
• • Positive for indirect antiglobulin test (Indirect Coombs test);
• • Use of monoclonal antibody, cell therapy, etc. within 6 months before administration, or daratumumab or its analogues or drugs targeting CD38 before administration;
• • Use of any medication, including prescription drugs, over-the-counter (OTC) drugs, and Chinese herbal medicines, within 2 weeks before administration;
• • History of drug or food allergy, including allergy to any drug or drug excipient used in the study;
• • Fear of needles or blood, or difficulty in venous blood collection (history of difficult blood collection or corresponding symptoms and signs, unable to tolerate venipuncture);
• • History of blood donation or total blood loss of 200 mL or more within 3 months before administration;
• • Participants in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long (5 half-lives \> 3 months)) before administration;
• • Major surgery within 3 months before signing the ICF;
• • Positive for hepatitis B virus antibodies, hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV), or treponema pallidum antibodies (Anti-TP);
• • History of drug abuse or substance abuse, or positive in urine drug screening;
• • Patients who have been vaccinated with attenuated or live virus vaccine (such as Bacille Calmette-Guérin, BCG) or viral vector vaccine within 12 months before the first dose, or who plan to be vaccinated with such vaccines within 12 months after administration;
• • Patients who have been vaccinated with vaccines other than the above attenuated or live viral vaccines and viral vector vaccines within 1 month before the first dose, such as inactivated vaccines and recombinant subunit vaccines;
• • Subjects with any other conditions that, in the judgment of the investigator, are ineligible for participation in the study.