Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGInfliximab
100mg/vial
Sponsors
Taizhou Mabtech Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Biological: CMAB008 Biological: Remicade
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade | up to 1680 hours |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade | up to 1680 hours |
| Time of Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade | up to 1680 hours |
| Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single Infusion of CMAB008/Remicade | up to 1680 hours |
| Total Frequency of AE/SAE Within the Whole Time of the Study | up to 1680 hours |
| Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected | up to 1680 hours |
Countries
China
Outcome results
None listed