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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT01284036

Run by

Ablynx, a Sanofi company

People needed

63

Starts

2010-10-01

Expected to finish

2011-11-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Investigational Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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