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Completed

NCT Number: NCT01740609

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo

PF-06342674 Dose A

Biological

Single SC Dose

PF-06342674 Dose B

Biological

Single SC Dose

PF-06342674 Dose C

Biological

Single SC Dose

PF-06342674 Dose D

Biological

Single SC Dose

PF-06342674 Dose E

Biological

Single SC Dose

PF-06342674 Dose F

Biological

Single IV Dose

PF-06342674 Dose G

Biological

Single SC Dose

PF-06342674 Dose H

Biological

Single IV Dose

PF-06342674 Dose I

Biological

Single SC Dose

PF-06342674 Dose J

Biological

Single IV Dose

Primary outcomes

  1. Incidence of dose limiting or intolerable treatment related AEs

    Time frame: 60 days

  2. Incidence of treatment emergent AEs

    Time frame: 60 days

  3. Incidence of abnormal laboratory findings

    Time frame: 60 days

  4. Changes from baseline in safety laboratory assessments

    Time frame: 60 days

  5. Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters

    Time frame: 60 days

  6. Incidence of anti-drug-antibodies

    Time frame: 60 days

  7. Severity of treatment emergent AEs

    Time frame: 60 days

  8. Causal relationship of treatment emergent AEs

    Time frame: 60 days

Secondary outcomes

  1. 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.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 60 days

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 60 days

  4. PK parameter estimates including T1/2.

    Time frame: 60 days

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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