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

Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04779892
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
4.4
Actual Duration (Months)
20.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Biological: CMAB008 Biological: RemicadeBiological: CMAB008 Biological: Remicade
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Jun 15, 2020
Actual Study Completion Date :
Jun 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CMAB008

Drug: Infliximab
100mg/vial
Active Comparator: Remicade

Drug: Infliximab
100mg/vial

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade [up to 1680 hours]

  2. Time of Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade [up to 1680 hours]

  3. 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]

  4. Total Frequency of AE/SAE Within the Whole Time of the Study [up to 1680 hours]

  5. Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected [up to 1680 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Xuhui Central Hospital Shanghai Shanghai China 200031

Sponsors and Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taizhou Mabtech Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT04779892
Other Study ID Numbers:
  • CMAB008HV-I
First Posted:
Mar 3, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Infliximab

Study Results

No Results Posted as of Oct 11, 2021