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

NCT06371534 | Recruiting Phase 1

• 1 other identifier: QL2109-101
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• AUC0-∞

  To evaluate pharmacokinetic similarity between QL2109 and DARZALEX FASPRO ® after a single subcutaneous injection in healthy volunteers

  112 day

• Cmax

  To evaluate pharmacokinetic similarity between QL2109 and DARZALEX FASPRO® after a single subcutaneous injection in healthy volunteers

  112 day

Study Arms (2)

QL2109

EXPERIMENTAL

QL2109, subcutaneous injection 3-5 min D1 (Day 1, single dose)

Drug: QL2109

DARZALEX FASPRO®

ACTIVE COMPARATOR

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

Drug: DARZALEX FASPRO®

Interventions

QL2109 DRUG

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

QL2109

DARZALEX FASPRO® DRUG

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

DARZALEX FASPRO®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: April 12, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-04

Locations

CN (2)