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Completed

NCT Number: NCT01870986

Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06410293

Biological

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Other names: adalimumab-Pfizer

Humira (adalimumab-EU)

Biological

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Other names: adalimumab (European Union)

Humira (adalimumab-US)

Biological

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Other names: adalimumab (United States)

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Day 1 - Day 43

  2. Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)

    Time frame: Day 1 - Day 43

  3. Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)

    Time frame: Day 1 - Day 43

Secondary outcomes

  1. Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)

    Time frame: Day 1 - Day 71

  2. Time to Reach Maximum Observed Serum Concentration (Tmax)

    Time frame: Day 1- Day 43

  3. Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing

    Time frame: Day 1- Day 43

  4. Systemic Clearance (CL)

    Time frame: Day 1- Day 43

  5. Serum Decay Half-Life (t1/2)

    Time frame: Day 1- Day 43

    Serum decay half-life is teh time for the serum concentration to decrease by one half

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2013
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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