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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: PF-06410293; Biological: Humira (adalimumab-EU); Biological: Humira (adalimumab-US)

• Registration Number: NCT01870986
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-03
• Study First Posted: 2013-06-06
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PF-06410293	PF-06410293
B	Humira (adalimumab-EU)	Adalimumab-EU
C	Humira (adalimumab-US)	Adalimumab-US

Primary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)	Day 1 - Day 43
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

Secondary Outcome Measures

Name	Time	Method
Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)	Day 1 - Day 71
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
Systemic Clearance (CL)	Day 1- Day 43
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Brussels, Belgium