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

June 17, 2014 updated by: Pfizer

A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1. Placebo
Placebo
Drug: Placebo
Placebo
Experimental: 2.0
Biological: PF-06342674 Dose A
Single SC Dose
Biological: PF-06342674 Dose B
Single SC Dose
Biological: PF-06342674 Dose C
Single SC Dose
Biological: PF-06342674 Dose D
Single SC Dose
Biological: PF-06342674 Dose E
Single SC Dose
Biological: PF-06342674 Dose F
Single IV Dose
Biological: PF-06342674 Dose G
Single SC Dose
Biological: PF-06342674 Dose H
Single IV Dose
Biological: PF-06342674 Dose I
Single SC Dose
Biological: PF-06342674 Dose J
Single IV Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose limiting or intolerable treatment related AEs
Time Frame: 60 days
60 days
Incidence of treatment emergent AEs
Time Frame: 60 days
60 days
Incidence of abnormal laboratory findings
Time Frame: 60 days
60 days
Changes from baseline in safety laboratory assessments
Time Frame: 60 days
60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
Time Frame: 60 days
60 days
Incidence of anti-drug-antibodies
Time Frame: 60 days
60 days
Severity of treatment emergent AEs
Time Frame: 60 days
60 days
Causal relationship of treatment emergent AEs
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the Concentration-Time Curve (AUC)
Time Frame: 60 days
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
60 days
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 60 days
60 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 60 days
60 days
PK parameter estimates including T1/2.
Time Frame: 60 days
60 days
Systemic Clearance (CL)
Time Frame: 60 days
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
60 days
Apparent Oral Clearance (CL/F)
Time Frame: 60 days
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
60 days
Apparent Volume of Distribution (Vz/F)
Time Frame: 60 days
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B4351001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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