A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: PF-06342674 Dose A; Biological: PF-06342674 Dose E; Biological: PF-06342674 Dose F; Biological: PF-06342674 Dose I; Biological: PF-06342674 Dose B; Biological: PF-06342674 Dose C; Biological: PF-06342674 Dose J; Drug: Placebo; Biological: PF-06342674 Dose D; Biological: PF-06342674 Dose H; Biological: PF-06342674 Dose G

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740609

B4351001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
• BMI between 18.5 to 32 kg/m2.
• Total body weight ≥40 kg and ≤120 kg.

Exclusion criteria

• Previous treatment with an antibody within 6 months prior to Day 1.
• Pregnant or nursing females; females of childbearing potential.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

1. Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2.0

Experimental group

Treatment:

Biological: PF-06342674 Dose G

Biological: PF-06342674 Dose H

Biological: PF-06342674 Dose D

Biological: PF-06342674 Dose J

Biological: PF-06342674 Dose C

Biological: PF-06342674 Dose B

Biological: PF-06342674 Dose I

Biological: PF-06342674 Dose F

Biological: PF-06342674 Dose E

Biological: PF-06342674 Dose A