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Dose Escalation Study of PF-06741086 In Healthy Subjects

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Biological: PF-06741086

Study type

Interventional

Funder types

Industry

Identifiers

NCT02531815
B7841001
2015-001821-17 (EudraCT Number)

Details and patient eligibility

About

This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.

Enrollment

41 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).

Exclusion criteria

  • Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
  • Use of nicotine/tobacco products
  • Clotting disorders

Trial design

41 participants in 8 patient groups

Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 2 (SC) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 3 (SC) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 4 (Intravenous [IV]) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 5 (IV) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 6 (IV) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 7 (IV) PF-06741086, Placebo
Experimental group
Treatment:
Biological: PF-06741086
Drug: Placebo
Cohort 8 (subcutaneous [SC]) PF-06741086
Experimental group
Treatment:
Biological: PF-06741086

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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