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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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