CO 3389-0007

 

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 UDENYCA 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 chemothereapy.

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Or call 210-225-5437 for more information

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

To determine if you fully qualify, it will be necessary to obtain blood samples after a 12- hour fast.  You have the option of fasting for the screening appointment, or, you may return later.   For more information, see below.

Qualified participants may be compensated up to $8,500 for time and travel. Partial stipend payment available.

STUDY DATES

All dates & times are tentative and may change.	Group 1
1st Admit	Mar 09, 2021
Discharge	Mar 14
Outpatient Visit	Mar 15
Outpatient Visit	Mar 16
Outpatient Visit	Mar 17
Outpatient Visit	Mar 18
Outpatient Visit	Mar 19
Outpatient Visit	Mar 20
Outpatient Visit	Mar 22
Outpatient Visit	Mar 30
Outpatient Visit	Apr 07
2nd Admit	Apr 19, 2021
Discharge	Apr 24
Outpatient Visit	Apr 25
Outpatient Visit	Apr 26
Outpatient Visit	Apr 27
Outpatient Visit	Apr 28
Outpatient Visit	Apr 29
Outpatient Visit	Apr 30
Outpatient Visit	May 02
Outpatient Visit	May 10
Outpatient Visit	May 18

 

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, diaphragm, sponge with spermicide from check in to at least 90 days after the last dose of study drug
• 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.