Skip to main content
OpenTrials
Completed

NCT Number: NCT01284036

A Single Dose Study Of The Safety And Investigational Product Level Measurement In 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Tacoma, Washington, 98418, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-05230905

Drug

Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study title

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

Acronym: FIH

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.