ICON Early Phase Services is conducting a research study for healthy non-smoking males ages 18-45. The purpose of this study is to compare an FDA approved drug administered through a pre-filled syringe or an auto injector. The injections will be given subcutaneously under the skin. The study drug is being used to reduce the risk of infections in patients receiving chemotherapy.
Clinical trial study for healthy non-smoking males ages 18-45 – CO 3389-0007
Vital signs, ECGs, physical examinations, drug and alcohol testing will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
• Screening visit
•10 Non-consecutive overnights (2 periods of 5 overnights)
•18 Outpatient visits
If you are able to answer “YES” to the following statements, you may qualify for this study.
I am a healthy non-smoking male , meaning no significant medical conditions
I am between 18 and 45 years old
My BMI is between 18.0 and 28.0 kg/m2 and my weight is between 110 and 220 pounds
I have not participated in a clinical trial within 30 days prior to screening
My GFR is greater than 60mL/Min/1.73 m2
I agree to refrain from sperm donation and use barrier contraception such as male condom, from Period 1 check in to at least 90 days after the last dose of study drug. Vasectomy or total abstinence from hetero sexual activity that could result in conception, as the preferred lifestyle of the subject, are also acceptable.
I am able to communicate effectively in English with the study personnel
I have suitable veins for multiple blood samples
Screening Reminders –
12 hours fasting is required for lab work (only water is allowed)
If taking medications, bring them to your screening appointment.
Bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver’s license, state issued ID card, military ID or passport. You will be required to show this same photo ID at all study visits.
Arrive 30 minutes before your appointment to complete paper work.
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA