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

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

September 29, 2010
January 26, 2011
January 31, 2013
October 2010
November 2011   (Final data collection date for primary outcome measure)
  • Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo. [ Time Frame: day 168 ]
  • Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated. [ Time Frame: 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. [ Time Frame: day 168 ]
Same as current
Complete list of historical versions of study NCT01284036 on ClinicalTrials.gov Archive Site
  • Incidence of development of Anti Drug Antibody. [ Time Frame: day 168 ]
  • Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters. [ Time Frame: day 168 ]
  • Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined. [ Time Frame: day 168 ]
Same as current
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A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
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).
First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects
Phase 1
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Drug: PF-05230905
Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo
9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo
Intervention: Drug: PF-05230905
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2011
November 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Study Director: Josefin-Beate Holz, MD Ablynx
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP