Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Adalimumab, Biosimilar Pharmaceuticals
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.
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.
Interventions
BIOLOGICALBMO-2
Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).
BIOLOGICALEU-Humira
Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)
BIOLOGICALUS-Humira
Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).
Sponsors
Mylan GmbH
Mylan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. Other protocol-defined inclusion/
Exclusion criteria
may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Tolerability assessments as measured by injection site reactions |
| Safety variable - immunogenicity (Presence of anti-adalimumab antibodies) | Day 1 (pre-dose) and Day 9, 29, and 71 days post subcutaneous injection. | Presence of anti-adalimumab antibodies |
Countries
Belgium
Outcome results
None listed