Healthy Subjects
Conditions
Keywords
healthy subjects, immunology, PK, Phase 1, bioequivalence, biosimilarity, adalimumab, single dose.
Brief summary
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers
Interventions
BIOLOGICALPF-06410293
PF-06410293 will be administered as a single 40 mg, subcutaneous dose
BIOLOGICALAdalimumab-US
Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
BIOLOGICALAdalimumab-EU
Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests. * Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight \>60 kg (132 lbs). * Chest X ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximal serum concentration (Cmax) | Day 1 - Day 50 | maximal serum concentration (Cmax) |
| area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) | 0-336 hours | area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] | Day 1 - Day 50 | AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) |
| AUC extrapolated to infinity (AUC0inf) | Day 1 - Day 50 | AUC extrapolated to infinity (AUC0inf) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 | AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US |
| AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 | AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US |
| time to reach the maximum concentration (Tmax) | Day 1 - Day 50 | time to reach the maximum concentration (Tmax) |
| Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters | Day 1- Day 71 | Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters |
| Apparent volume of distribution (Vz/F) | Day 1 - Day 50 | Apparent volume of distribution (Vz/F) |
| Terminal half-life (T1/2) | Day 1 - Day 50 | Terminal half-life (T1/2) |
| Apparent clearance (CL/F) | Day 1 - Day 50 | Apparent clearance (CL/F) |
| Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) | Day 1- Day 71 | Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) |
| maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 | maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US |
| area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US | 0-336 hours | area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US |
Countries
United States
Outcome results
None listed