The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
- Registration Number
- NCT04779892
- Lead Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 90
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CMAB008 Infliximab - Remicade Infliximab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Total Frequency of AE/SAE Within the Whole Time of the Study 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 Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade up to 1680 hours Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected up to 1680 hours
Trial Locations
- Locations (1)
Shanghai Xuhui Central Hospital
🇨🇳Shanghai, Shanghai, China