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

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. Identifier: NCT01284036
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-05230905 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects
Study Start Date : October 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo. [ Time Frame: day 168 ]
  2. Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated. [ Time Frame: day 168 ]
  3. 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. [ Time Frame: day 168 ]

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

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

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.

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 identifier (NCT number): NCT01284036

United States, Washington
Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Study Director: Josefin-Beate Holz, MD Ablynx

Responsible Party: Ablynx Identifier: NCT01284036     History of Changes
Other Study ID Numbers: B2331001
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Ablynx:
Healthy subject
PK study
healthy volunteers