Clinical trial NCT04779892: The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Official title: The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Biological: CMAB008 Biological: Remicade
Primary purpose: OTHER

Brief summary: A phase 1, Randomized, Double-blind, Parallel group, Sing-dose study to compare the Pharmacokinetics and Safety of CMAB008 and Remicade in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subject (male) between the ages of 18 and 45 years.
* Subject with a body weight of ≥50 kg and ≤ 80 kg and a BMI between 19.0\~26.0 kg/m2 (both inclusive);
* Healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead electrocardiogram;

Exclusion Criteria:

* Those who have surgered 4 weeks before signing the informed consent;
* Those with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor, blood, endocrine, nervous and other system diseases, or those with any previous immune diseases;
* Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 4 weeks before signing the informed consent;
* Those who accepted biological drugs within 6 months before signing the informed consent, or accepted the TNF monoconal antibody drugs;
* Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponema pallidum antibody is positive;
* Either T cell immunospot test (T-SPOT) or antinuclear antibody is positive;
* Those who have infected within 30 days before administration, or serious infection associated with hospitalisation and/or which required inrravenous antibiotics within 3 months before administration.
* Vaccinated within 30 months before signing the informed conset, or plan to vaccinate during the trail;
* Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior to the trail; those who have positive drug abuse test results;
* Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 250ml per cup) every day;
* Those who have a blood donation history of 400 ml within 3 months, or 200 ml within 1 month;
* Those who have a history of drug or food allergy, or are known to be allergic to any component of the test drug or latex, etc.
* Those who are addicted to smoking or smoke more than 10 cigarettes per day on average within 6 months before signing the informed consent;
* Alcoholics or regular drinkers within 3 months before the trail, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive;
* Those who plan to donate sperm within 6 months after the adminstration of the test drug;

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade
timeFrame: up to 1680 hours
Secondary outcomes:
measure: Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade
timeFrame: up to 1680 hours
measure: Time of Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade
timeFrame: up to 1680 hours
measure: Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single Infusion of CMAB008/Remicade
timeFrame: up to 1680 hours
measure: Total Frequency of AE/SAE Within the Whole Time of the Study
timeFrame: up to 1680 hours
measure: Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected
timeFrame: up to 1680 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: