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

NCT ID: NCT04779892

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-06-15

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

CMAB008

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: DRUG

100mg/vial

Remicade

Group Type: ACTIVE_COMPARATOR

Infliximab

Intervention Type: DRUG

100mg/vial

Interventions

Infliximab

100mg/vial

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taizhou Mabtech Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Su Y, Li J, Wang C, Zhang X, Hou S, Guo H, Deng C, Ou L, Wang J. Population Pharmacokinetics of CMAB008 (an Infliximab Biosimilar) and Remicade(R) in Healthy Subjects and Patients with Moderately to Severely Active Rheumatoid Arthritis. Adv Ther. 2023 Mar;40(3):1005-1018. doi: 10.1007/s12325-022-02396-8. Epub 2023 Jan 6.

Reference Type: DERIVED

PMID: 36607544 (View on PubMed)

Other Identifiers

CMAB008HV-I

Identifier Type: -

Identifier Source: org_study_id