HealthyPhase 1NCT02912247

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

A Phase 1 study testing human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and adalimumab in people with Healthy, run by Innovent Biologics (Suzhou) Co. Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 183 participants
Where: No sites listed yet
Study dates: 27 Oct 2016to 22 Sep 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

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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;
Use a live vaccine within 3 months prior to administration;
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;
Unwilling to use adequate contraception(such as condoms) during the study period;
Evidence suggests presence of clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, or neurologic abnormality;
Mentally impaired;
Disabilities, bed rest, wheelchair dependent, or lack of activity of daily life;
Subjects who are unsuited to the study for any reason, judged by the investigators.

About this study

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

Read the 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.

Conditions: Healthy
Being tested: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, adalimumab
Keywords: tumor necrosis factor-a blocker, pharmacokinetics, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02912247
Study group	Role	What they receive
monoclonal antibody injection	Experimental	human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once Receives: Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection
adalimumab	Active comparator	adalimumab 40mg administered subcutaneously once Receives: Drug: adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)
Measured: 71days
Area under the concentration-time curve from time zero to infinity(AUCinf)
Measured: 71days
Maximum serum concentration(Cmax)
Measured: 71days

Secondary outcomes (5)

Time to reach the maximum concentration(Tmax)
Measured: 71days
Elimination rate constant(γz)
Measured: 71days
Terminal half-live(T1/2)
Measured: 71days
Apparent clearance(CL/F)
Measured: 71days
Apparent volume of distribution(V/F)
Measured: 71days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 201622 Sep 2017

First posted23 Sep 2016 (estimated)
Study start27 Oct 2016
Primary completion22 Sep 2017
Study completion22 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02912247
Sponsor's protocol ID: CIBI303A201
Status last verified: Jun 2018
First submitted: 21 Sep 2016
Last updated: 7 Mar 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02912247
Acronym / sponsor ID: CIBI303A201
Conditions: Healthy
Keywords: tumor necrosis factor-a blocker, pharmacokinetics, safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 27 Oct 2016 (actual)
Primary completion: 22 Sep 2017 (actual)
Study completion: 22 Sep 2017 (actual)
First posted: 23 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
monoclonal antibody injection	Experimental	Drug: human recombinant anti-tumor necrosis factor alpha monoclonal antibody injectionhuman recombinant anti-tumor necrosis factor alpha monoclonal antibody injection 40mg administered subcutaneously once
adalimumab	Active comparator	Drug: adalimumabadalimumab 40mg administered subcutaneously once

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (22 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
human recombinant anti-tumor necrosis factor alpha monoclonal antibody injectionhuman recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once	Drug	monoclonal antibody injection
adalimumabadalimumab, 40mg,subcutaneous injection,once	Drug	adalimumab

Primary outcome

Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast)
Time frame: 71days
Area under the concentration-time curve from time zero to infinity(AUCinf)
Time frame: 71days
Maximum serum concentration(Cmax)
Time frame: 71days

5 secondary outcomes

Time to reach the maximum concentration(Tmax)
Time frame: 71days
Elimination rate constant(γz)
Time frame: 71days
Terminal half-live(T1/2)
Time frame: 71days
Apparent clearance(CL/F)
Time frame: 71days
Apparent volume of distribution(V/F)
Time frame: 71days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bei Hu, Professor principal investigator

Peking Union Medical College Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and adalimumab in people with Healthy, run by Innovent Biologics (Suzhou) Co. Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve from time zero to the last quantifiable concentration(AUClast) (time frame: 71days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02912247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.