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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT01284036
First received: September 29, 2010
Last updated: January 30, 2013
Last verified: January 2013

September 29, 2010
January 30, 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated. [ Time Frame: day 168 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters. [ Time Frame: day 168 ] [ Designated as safety issue: No ]
  • Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined. [ Time Frame: day 168 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy
Drug: PF-05230905
Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo
PF-05230905
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284036
B2331001, 3294K1-1000
No
Ablynx
Ablynx
Not Provided
Study Director: Josefin-Beate Holz, MD Ablynx
Ablynx
January 2013

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