Healthy OL 3426-0009

  • STATUS
    Recruiting
Updated on 9 June 2020

Summary

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.

Description

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.

 

Details
Condition *Healthy Volunteers
Clinical Study IdentifierTX245630
Last Modified on9 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Other Details: Qualified participants may be compensated up to $4,000 for time and travel
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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