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
  Purpose

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 Intervention Phase
Healthy
Drug: PF-05230905
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects

Further study details as provided by Ablynx:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284036

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

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01284036     History of Changes
Other Study ID Numbers: B2331001, 3294K1-1000
Study First Received: September 29, 2010
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ablynx:
Healthy subject
safety
PK study
healthy volunteers

ClinicalTrials.gov processed this record on April 15, 2014