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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740609
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : June 19, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Biological: PF-06342674 Dose A Biological: PF-06342674 Dose B Biological: PF-06342674 Dose C Biological: PF-06342674 Dose D Biological: PF-06342674 Dose E Biological: PF-06342674 Dose F Biological: PF-06342674 Dose G Biological: PF-06342674 Dose H Biological: PF-06342674 Dose I Biological: PF-06342674 Dose J Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
Study Start Date : November 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740609


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01740609    
Other Study ID Numbers: B4351001
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014
Keywords provided by Pfizer:
Phase 1
RN168
Healthy Volunteers