The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety

• Status: Completed
• Trial end date: 2020-06-15
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
• Treatments: Infliximab

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;