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CompletedNCT04779892Updated Oct 11, 2021

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

A Phase 1 interventional study of Infliximab in Rheumatoid Arthritis, sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2020, registered Feb 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 90 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Taizhou Mabtech Pharmaceutical Co.,Ltd is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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;
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    CMAB008

    Drug: Infliximab

  • Active comparator
    Remicade

    Drug: Infliximab

Interventions

  • DrugInfliximab

    100mg/vial

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade

    Time frame: up to 1680 hours

Secondary outcomes

  1. Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade

    Time frame: up to 1680 hours

  2. Time of Maximum Concentration of Infliximab After the Single Infusion of CMAB008/Remicade

    Time frame: 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

    Time frame: up to 1680 hours

  4. Total Frequency of AE/SAE Within the Whole Time of the Study

    Time frame: up to 1680 hours

  5. Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected

    Time frame: up to 1680 hours

07

Study locations

1 site
  • Shanghai Xuhui Central Hospital
    Shanghai, Shanghai 200031, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04779892
Lead sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Responsible party
Sponsor
First posted
Mar 3, 2021
Start date
Feb 1, 2020
Primary completion
Jun 15, 2020
Completion
Jun 15, 2020
Last update
Oct 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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