ICON Early Phase Services is conducting a research study for healthy adults ages 18-45. This study is being done to test a potential treatment for botulism. The study drug will be administered by intramuscular injection.
Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
1 screening visit
1 day in-clinic
11 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at
screening. For more information, see below.
Qualified participants may be compensated up to $4,000 for time and travel.
If you are able to answer “YES” to the following statements, you may qualify for this study.
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.
Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.
No guarantees can be made regarding group assignments for any particular study ICON will not assume liability for lost time, travel or failure to qualify.
To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8-hour fast. You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples.
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. We will be testing for drug abuse and alcohol. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment.
Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to 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.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.
Be advised that you may need to provide medical records as part of the screening process for this study. If possible, please bring your full medical records with you to your screening appointment. If you cannot bring your records with you, you must provide them before you can admit to the study. Note that full medical records include surgical reports. You will not be allowed to participate in the study without medical records defined as:
If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:
*Compensation in multiple payments.
STUDY DATES - Note: All dates and times are tentative and may change. You cannot pick which cohort you go into.
|Day 0 - Dose, 12hours +/- visit||July 06, 2020 Mon|
|Day 1||July 07 Tue|
|Day 2||July 08 Wed|
|Day 3||July 09 Thurs|
|Day 4||July 10 Fri|
|Day 8||July 14 Tue|
|Day 15||July 21 Tue|
|Day 30||Aug 05 wed|
|Day 45||Aug 20 Thurs|
|Day 60||Sep 04 Fri|
|Day 90||Oct 04 Sun|
|Day 120||Nov 03 Tue|
|Day 0 - Dose, 12hours +/- visit||July 08, 2020 Wed|
|Day 1||July 09 Thurs|
|Day 2||July 10 Fri|
|Day 3||July 11 Sat|
|Day 4||July 12 Sun|
|Day 8||July 16 Thurs|
|Day 15||July 23 Thurs|
|Day 30||Aug 07 Fri|
|Day 45||Aug 22 Sat|
|Day 60||Sep 06 Sun|
|Day 90||Oct 06 Tue|
|Day 120||Nov 05 Thurs|
In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password
protected database. Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.
It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed. You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.
PURSUANT TO SECTION 30.06,
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN)
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.