Trial Title:
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults
NCT ID:
NCT06371534
Condition:
Tumor
Conditions: Official terms:
Daratumumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
QL2109
Description:
subcutaneous injection 3-5 min D1 (Day 1, single dose)
Arm group label:
QL2109
Intervention type:
Drug
Intervention name:
DARZALEX FASPRO®
Description:
subcutaneous injection 3-5 min D1 (Day 1, single dose)
Arm group label:
DARZALEX FASPRO®
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.
Detailed description:
This is a phase I, randomized, double-blind and parallel group clinical trial . The
primary objective is to assess the pharmacokinetic similarity of single injections of
QL2109 or DARZALEX FASPRO in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity
of single injections of QL2109 or DARZALEX FASPRO® in healthy volunteers.
Subjects would receive a single 1800mg#15ml# of QL2109 or DARZALEX FASPRO® injection.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. 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; 2. Age 18 ~ 50 (inclusive) years , male; 3. 65.0
kg≤ body weight ≤90.0 kg and 18.0 kg/m2≤ Body mass index (BMI)
- 28.0 kg/m2; 4. 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; 5. 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:
-
1. 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; 2.With acute, chronic, or latent infectious
diseases within 1 month before administration; 3.With known immune system
diseases (autoimmune diseases and immunodeficiency diseases), including but not
limited to autoimmune hemolytic anemia; 4.Has experienced a recent single
dermatomal herpes zoster eruption within 6 months before administration; 5.Has
a history of multi-dermatomal herpes zoster or central nervous system (CNS)
herpes zoster during the screening period or before; 6.Positive for indirect
antiglobulin test (Indirect Coombs test); 7.Use of monoclonal antibody, cell
therapy, etc. within 6 months before administration, or daratumumab or its
analogues or drugs targeting CD38 before administration; 8.Use of any
medication, including prescription drugs, over-the-counter (OTC) drugs, and
Chinese herbal medicines, within 2 weeks before administration; 9.History of
drug or food allergy, including allergy to any drug or drug excipient used in
the study; 10.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); 11.History of blood donation or total
blood loss of 200 mL or more within 3 months before administration;
12.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; 13.Major
surgery within 3 months before signing the ICF; 14.Positive for hepatitis B
virus antibodies, hepatitis C virus (HCV) antibodies, human immunodeficiency
virus (HIV), or treponema pallidum antibodies (Anti-TP); 15.History of drug
abuse or substance abuse, or positive in urine drug screening; 16.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; 17.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; 18.Subjects with any other conditions that, in the judgment
of the investigator, are ineligible for participation in the study.
Gender:
Male
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Contact:
Last name:
qingwei zhao, Professor
Email:
qwzhao@zju.edu.cn
Investigator:
Last name:
qingwei zhao, Professor
Email:
Principal Investigator
Investigator:
Last name:
xingjiang hu, Professor
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Contact:
Last name:
qingwei ZHAO, Professor
Email:
qwzhao@zju.edu.cn
Contact backup:
Last name:
xingjiang HU, Professor
Email:
hxj319@163.com
Investigator:
Last name:
qingwei ZHAO, Professor
Email:
Principal Investigator
Investigator:
Last name:
xingjiang HU, Professor
Email:
Principal Investigator
Start date:
April 2024
Completion date:
April 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06371534
