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.

  • I am a healthy adult, meaning no significant medical conditions
  • I am between 18 and 45 years old on dosing day
  • My BMI is between 18.5 and 35.0 kg/m2 (inclusive)  and I weigh at least 99 lbs.
  • I have not received any investigational drug within 28 days of dosing
  • I am not enrolled in, or plan to enroll in, any other clinical trial during the study period
  • If Female, I am not pregnant or breastfeeding   
  • If Female and capable of becoming pregnant, I agree to practice sexual abstinence (with men) , or use and IUD, during participation in the study
  • If Female and not capable of becoming pregnant I am one of the following:
    • Postmenopausal for at least 1 year
    • Surgically sterile (both ovaries removed, uterus removed, or tubes tied)
    • Successful Essure placement with documented confirmation test at least 3 months after the procedure                                      
  • I do not use any tobacco or nicotine products and I agree not to smoke for the duration of the study and to abide by the rules of the clinic (which is a non-smoking facility) 
  • I am able to communicate effectively in English with the study personnel
  • I do not have a history of any chronic medical condition (except for low-grade skin cancer thought to be cured and previous asthma which has not been treated in the past year)
  • History of severe allergic reaction to any type of medication, bee stings, food, or environmental factors, or hypersensitivity or reaction to immunoglobulins
  • I have not recently donated blood
  • I have not been treated with a monoclonal antibody within 3 months of enrollment (consent)
  • I have not received an antibody or blood transfusion within 6 months or 5 half-lives of the product given
  •  I do not have an active drug or alcohol dependence
  •  I have not used H1 antihistamines or beta-blockers within 5 days of dosing
  • I have not used any prohibited medication within 28 days prior to study entry or plan to use during the study period. Prohibited medication include immunosuppressives (except for NSAIDS, immune modulators, oral corticosteroids [topical/intranasal steroids are acceptable], anti-neoplastic agents, any vaccine)
  • I have not had any previous exposure to botulinum toxin, receipt of antibodies against botulinum toxin, or previous treatment with equine antitoxin
  • I have not had any previous injection or planned injection within 4 months after enrollment of botulinum toxin (e.g.,cosmetic reasons, spastic dysphonia, torticollis, or any other reason)

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: 

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation.

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:

CLICK HERE to make an appointment for OL3426-0009

*Compensation in multiple payments.

STUDY DATES - Note: All dates and times are tentative and may change. You cannot pick which cohort you go into.

Cohort 2A

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

 

Cohort 2B

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

Notice:

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.

Name
Healthy OL 3426-0009
Details
Not currently screening
Gender
Male or Female
Payment amount
up to $4,000
Age
18 - 45
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