Healthy
Conditions
Keywords
Healthy Volunteers, Phase 1, PK, adalimumab, Single-dose, Immunology, Bioequivalence, Biosimilarity, Similarity.
Brief summary
This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.
Interventions
BIOLOGICALPF-06410293
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
BIOLOGICALHumira (adalimumab-EU)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
BIOLOGICALHumira (adalimumab-US)
40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
Exclusion criteria
* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day 1 - Day 43 |
| Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast) | Day 1 - Day 43 |
| Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf) | Day 1 - Day 43 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Clearance (CL) | Day 1- Day 43 | — |
| Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab) | Day 1 - Day 71 | — |
| Serum Decay Half-Life (t1/2) | Day 1- Day 43 | Serum decay half-life is teh time for the serum concentration to decrease by one half |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Day 1- Day 43 | — |
| Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing | Day 1- Day 43 | — |
Countries
Belgium, United States
Outcome results
None listed