A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects (FIH)

Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects

The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-05230905

Detailed Description

First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98418
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• Receipt or treatment with an investigational or marketed biologic drug.
• blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PF-05230905; 9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo	Drug: PF-05230905; Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.	day 168
Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.	day 168
Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects.	day 168

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of development of Anti Drug Antibody.	day 168
Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters.	day 168
Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined.	day 168

Collaborators and Investigators

• Sponsor: Ablynx

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 29, 2010
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: safety; healthy volunteers; PK study; Healthy subject
• Other Study ID Numbers: B2331001; 3294K1-1000