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Trial record 7 of 558 for:    Cachectin OR Tumor Necrosis Factor-alpha

Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02912247
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection Drug: adalimumab Phase 1

Detailed Description:
This is a comparative, open, randomized clinical study. The purpose of the study is to demonstrate that human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection is equivalent to adalimumab in terms of pharmacokinetics and safety after single subcutaneous injection in Chinese healthy volunteers.The study will enroll 180 healthy volunteers, who will be randomized into 2 groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open, Randomized, Single-dose, Comparative Bioequivalency and Safety Study of Human Recombinant Anti-tumor Necrosis Factor Alpha Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
Actual Study Start Date : October 27, 2016
Actual Primary Completion Date : September 22, 2017
Actual Study Completion Date : September 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: monoclonal antibody injection
human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once
Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection
human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once

Active Comparator: adalimumab
adalimumab 40mg administered subcutaneously once
Drug: adalimumab
adalimumab, 40mg,subcutaneous injection,once




Primary Outcome Measures :
  1. Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast) [ Time Frame: 71days ]
  2. Area under the concentration-time curve from time zero to infinity(AUCinf) [ Time Frame: 71days ]
  3. Maximum serum concentration(Cmax) [ Time Frame: 71days ]

Secondary Outcome Measures :
  1. Time to reach the maximum concentration(Tmax) [ Time Frame: 71days ]
  2. Elimination rate constant(γz) [ Time Frame: 71days ]
  3. Terminal half-live(T1/2) [ Time Frame: 71days ]
  4. Apparent clearance(CL/F) [ Time Frame: 71days ]
  5. Apparent volume of distribution(V/F) [ Time Frame: 71days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male, age between 18 and 55;
  2. Body weight≥50kg and body mass index(BMI) within the range 19 to 28 kg/m2;
  3. To fully understanding the purpose of the study, to understand the pharmacological action of the study drugs and the possible adverse reactions; participants who are voluntary to sign the informed consent according to the Declaration of Helsinki.

Exclusion Criteria:

  1. History of adalimumab treatment;
  2. History of relevant allergy/hypersensitivity(including allergy to the study drug or its ingredient );
  3. Participation in another interventional trial within 3 months prior to administration of the study drug;
  4. Blood donation(more than 200 mL within 12 weeks prior to administration of the study drug);
  5. Use of any drugs(including traditional Chinese medicine) within 2 weeks or at least 5 half-lives(whichever is longer) prior to administration;
  6. History of cluster of differentiation 4 antagonist or tumor necrosis factor alpha antagonist use, or use tumor necrosis factor antagonist(such as thalidomide) 3 months prior to administration;
  7. Abnormal significant clinically chest radiograph, ECG, or laboratory examinations at screening and Baseline, judged by the investigators;
  8. History of opportunistic infection(s)(such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening;
  9. Known recurrent or chronic infectious disease(s) history, including but not limited to: chronic kidney infect, chronic chest infection(such as bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drainage or infected wounds of the skin;
  10. Tuberculosis(TB) history, or suspected clinically TB(including but not limited to: pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test;
  11. Positive serology for human immunodeficiency virus(HIV) antibody;
  12. Positive serology for hepatitis C virus antibody;
  13. Active or chronic hepatitis B virus infection, such as positive hepatitis B virus surface antigen;
  14. History of organ transplant(except for corneal transplantation≥3 months prior to Screening);
  15. Known immunodeficiency history;
  16. Use a live vaccine within 3 months prior to administration;
  17. Alcohol or drug abuse within 12 months prior to Screening; unwilling/inability to refrain from alcohol from 72 hours prior to administration and until during the trial period;
  18. Unwilling to use adequate contraception(such as condoms) during the study period;
  19. Evidence suggests presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, or neurologic abnormality;
  20. Mentally impaired;
  21. Disabilities, bed rest, wheelchair dependent, or lack of activity of daily life;
  22. Subjects who are unsuited to the study for any reason, judged by the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912247


Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Principal Investigator: Bei Hu, Professor Peking Union Medical College Hospital

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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT02912247     History of Changes
Other Study ID Numbers: CIBI303A201
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.:
tumor necrosis factor-a blocker
pharmacokinetics
safety

Additional relevant MeSH terms:
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Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Inflammatory Agents
Antirheumatic Agents