Adalimumab PK Bioequivalence Study to EU and US Sourced Humira

NCT02472912 | Completed Phase 1

• 2 other identifiers: MYL-HEB-10012014-000212-33
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Adalimumab; Biosimilar Pharmaceuticals

Outcome Measures

Primary Outcomes (1)

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

  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)

• Frequency of Adverse Events

  Up to 71 days.

• Safey variable - Tolerability (injection site reactions)

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

• Safety variable - immunogenicity (Presence of anti-adalimumab antibodies)

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

Study Arms (3)

Treatment A

EXPERIMENTAL

Single Injection of 40mg / 0.8 mL BMO-2

Biological: BMO-2

Treatment B

ACTIVE COMPARATOR

Single Injection of 40mg / 0.8 mL EU-Humira

Biological: EU-Humira

Treatment C

ACTIVE COMPARATOR

Single Injection of 40mg / 0.8 mL US-Humira

Biological: US-Humira

Interventions

BMO-2 BIOLOGICAL

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

Also known as: Adalimumab

Treatment A

EU-Humira BIOLOGICAL

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

Also known as: Adalimumab

Treatment B

US-Humira BIOLOGICAL

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

Also known as: Adalimumab

Treatment C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (1)

SGS Belgium NV

Antwerp, Belgium

Location

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

• Magdalena Petkova, MD

  SGS Belgium NV

  PRINCIPAL INVESTIGATOR

• Fausto Berti

  Mylan GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 16, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

BE (1)