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Healthy VolunteersPhase 1NCT02472912

Adalimumab PK Bioequivalence Study to EU and US Sourced Humira

A Phase 1 study testing BMO-2, EU-Humira and US-Humira in people with Healthy Volunteers, run by Mylan Inc. at 1 site in Belgium.

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

Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
BMO-2, EU-Humira and US-Humira
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteBelgium
Study dates
Dec 2014to Jun 2015
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Weight: 60.0-95.0 kg.
  • Body mass index (BMI) : 19.0-30.0 kg/m2, inclusive
  • Medical history without major pathology.
  • Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg.
  • Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology
  • Nonsmoker or light smoker
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  • Ability and willingness to abstain from alcohol from 48 h prior to drug administration and 48h prior to ambulatory visits, and during the stays in the clinical research center until discharge from the in-house period.
  • Fertile males and females participating in heterosexual sexual relations:willingness to use adequate contraception from screening until 90 days after the follow-up visit
  • Females must not lactate and must have a negative pregnancy test at screening and at admission
  • Differentiation of leukocytes, platelet count, hematocrit and hemoglobin results within the reference ranges. Minor deviations considered to lack any clinical relevance by the Principal Investigator can be accepted.
  • All other values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Principal Investigator.
  • Other protocol-defined inclusion/exclusion criteria may apply

Who cannot join

  • History of relevant drug and/or food allergies.
  • Hypersensitivity to Humira® or its constituents.
  • Known history of previous exposure to anti TNF-alpha molecules.
  • Any past or concurrent medical conditions potentially increasing the subject's risks. Examples of these include medical history with evidence of clinically relevant pathology (e.g., malignancies, demyelinating disorders).
  • Presence of chronic obstructive pulmonary disease (COPD). Asthma in the childhood is allowed
  • Any current active infections, including localized infections, or any recent history
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  • Treatment with non-topical medications (including over the counter medication, and herbal remedies such as St. John's Wort extract) within 7 days prior to study drug administration, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of acetaminophen, which may be used throughout the study.
  • History of active tuberculosis or presence of active or latent tuberculosis.
  • Having resided or traveled in regions where tuberculosis and mycosis are endemic within 90 days before screening, or who intend to visit such a region during the period of 3 months after dosing.
  • Having received live vaccines during the past 4 weeks before screening or have the intention to receive vaccination during the study.
  • Participation in a drug study within 60 days or 5 half-lives of the previous drug (if known), whichever is longer, prior to drug administration
  • Donation of more than 500 mL of blood within 8 weeks prior to drug administration.
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
  • Positive urine drug screen (opiates, methadone, cocaine, amphetamines (including XTC or metamphetamines), cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants) and positive alcohol breath test.
  • Positive screen on Hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus 1/2 antibodies (HIV).
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • SGS Belgium NV

    Antwerp

Other trials in Belgium

About this study

Official title: Single Center, Randomized, Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira, Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults

Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Injection in Healthy Adults.

Read the detailed description

This is a single-center, randomized, double-blind, 3-way parallel study in 270 healthy adult male and female subjects. During this study, the PK bioequivalence of BMO-2, containing 40 mg adalimumab, will be compared to EU licensed Humira® (EU-Humira® ) (40 mg) and US licensed Humira® (US-Humira® ) (40 mg).

Randomization will be stratified by body weight (weight categories of 60.0-79.9 kg and 80.0-95.0 kg). After randomization, subjects will receive one of the following treatments: a single sc injection of 40 mg BMO-2, an equivalent sc injection of EU-Humira® (40 mg), or an equivalent sc injection of US-Humira® (40 mg).

Volunteers participation in the study is expected to finish with the follow-up visit, scheduled 70 days after the injection of study drug.

Being tested
BMO-2, EU-Humira, US-Humira
Keywords
Pharmacokinetics, Adalimumab, Biosimilar Pharmaceuticals

What participants receive

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

  • BMO-2Biological

    Also called Adalimumab

    Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).

  • EU-HumiraBiological

    Also called Adalimumab

    Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)

  • US-HumiraBiological

    Also called Adalimumab

    Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).

Study groups in NCT02472912
Study groupRoleWhat they receive
Treatment AExperimentalSingle Injection of 40mg / 0.8 mL BMO-2
Receives: Biological: BMO-2
Treatment BActive comparatorSingle Injection of 40mg / 0.8 mL EU-Humira
Receives: Biological: EU-Humira
Treatment CActive comparatorSingle Injection of 40mg / 0.8 mL US-Humira
Receives: Biological: US-Humira

What is being measured

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

  1. Area under the plasma concentration versus time curve (AUC) of adalimumab.

    Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71 days post subcutaneous injection.

Secondary outcomes (3)

  1. Frequency of Adverse Events

    Measured: Up to 71 days.

  2. Safey variable - Tolerability (injection site reactions)

    Tolerability assessments as measured by injection site reactions

    Measured: Predose and 1, 2, 3, 7, 9, 36, and 71 days post subcutaneous injection.

  3. Safety variable - immunogenicity (Presence of anti-adalimumab antibodies)

    Presence of anti-adalimumab antibodies

    Measured: Day 1 (pre-dose) and Day 9, 29, and 71 days post subcutaneous injection.

Timeline

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

  1. First posted16 Jun 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472912
Sponsor's protocol ID
MYL-HEB-1001
Other IDs
2014-000212-33, 2014
Status last verified
Mar 2022
First submitted
3 Jun 2015
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMO-2, EU-Humira and US-Humira in people with Healthy Volunteers, run by Mylan Inc. at 1 site in Belgium.

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 12 inclusion and 16 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

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 plasma concentration versus time curve (AUC) of adalimumab. (time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71 days post subcutaneous injection.). 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 NCT02472912.

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 11 Mar 2022.

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