Clinical Trial 43670

San Antonio, TX 78209


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.

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.

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)

 


Qualified Participants May Receive:

Qualified participants may be compensated up to $4,000 for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.