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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Humira (adalimumab-US); Biological: PF-06410293; Biological: Humira (adalimumab-EU)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870986

REFLECTIONS B538-01

B5381001

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 3 patient groups

A

Experimental group

Description:

PF-06410293

Treatment:

Biological: PF-06410293

B

Active Comparator group

Description:

Adalimumab-EU

Treatment:

Biological: Humira (adalimumab-EU)

C

Active Comparator group

Description:

Adalimumab-US

Treatment:

Biological: Humira (adalimumab-US)