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

NCT02912247 | Completed Phase 1

• 1 other identifier: CIBI303A201
• Study Type: interventional
• Target: 183
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

tumor necrosis factor-a blocker; pharmacokinetics; safety

Outcome Measures

Primary Outcomes (3)

• Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)

  71days

• Area under the concentration-time curve from time zero to infinity(AUCinf)

  71days

• Maximum serum concentration(Cmax)

  71days

Secondary Outcomes (5)

• Time to reach the maximum concentration(Tmax)

  71days

• Elimination rate constant(γz)

  71days

• Terminal half-live(T1/2)

  71days

• Apparent clearance(CL/F)

  71days

• Apparent volume of distribution(V/F)

  71days

Study Arms (2)

monoclonal antibody injection

EXPERIMENTAL

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

adalimumab

ACTIVE COMPARATOR

adalimumab 40mg administered subcutaneously once

Drug: adalimumab

Interventions

human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection DRUG

human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once

monoclonal antibody injection

adalimumab DRUG

adalimumab, 40mg,subcutaneous injection,once

adalimumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, age between 18 and 55;
• Body weight≥50kg and body mass index(BMI) within the range 19 to 28 kg/m2;
• 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.

You may not qualify if:

• History of adalimumab treatment;
• History of relevant allergy/hypersensitivity(including allergy to the study drug or its ingredient );
• Participation in another interventional trial within 3 months prior to administration of the study drug;
• Blood donation(more than 200 mL within 12 weeks prior to administration of the study drug);
• Use of any drugs(including traditional Chinese medicine) within 2 weeks or at least 5 half-lives(whichever is longer) prior to administration;
• 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;
• Abnormal significant clinically chest radiograph, ECG, or laboratory examinations at screening and Baseline, judged by the investigators;
• History of opportunistic infection(s)(such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening;
• 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;
• Tuberculosis(TB) history, or suspected clinically TB(including but not limited to: pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test;
• Positive serology for human immunodeficiency virus(HIV) antibody;
• Positive serology for hepatitis C virus antibody;
• Active or chronic hepatitis B virus infection, such as positive hepatitis B virus surface antigen;
• History of organ transplant(except for corneal transplantation≥3 months prior to Screening);
• Known immunodeficiency history;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bei Hu, Professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: October 27, 2016
• Primary Completion: September 22, 2017
• Study Completion: September 22, 2017
• Last Updated: March 7, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share