Celiac Disease - San Antonio TX

Summary:

ICON Early Phase Services is conducting a research study for adults with celiac disease within the age range of 18-65. This study is being done to test the dosing level of an investigational drug for the treatment of celiac disease.  The study drug will be administered by IV infusion.

• 1 screening visit
• 3 consecutive overnights
• 4 outpatient visits
• 7 phone calls

To determine if you fully qualify, it will be necessary to obtain blood samples after a 10-hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. You may need to provide medical records to participate in this study.  For more information, see below.

 If you are able to answer “YES” to the following statements, you may qualify for this study.

• I am an adult with diagnosed celiac disease and I have had a biopsy to confirm that I have celiac disease 

• I am between 18 and 65 years old

• My BMI is between > 16 and ≤ 32.0 kg/m2   

• I have not been exposed to gluten for 2 months prior to enrollment for this study and I agree to maintain a gluten-free diet while on study

• I have not had uncontrolled celiac disease and/or complications of celiac disease or celiac symptoms within 8 weeks of screening

• I do not smoke or use any tobacco products and I have not used nicotine products within 6 months of screening.  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 have not received an investigational study drug within 30 days prior to 1st dose

• I agree not to participate in another investigational study while participating in this study

• If Female, I am not pregnant or breastfeeding and I do not plan to become pregnant before or during the study   

• If Female and capable of becoming pregnant, I agree to use a medically accepted method of contraception throughout the study and for 30 days after completing the study.  These methods include abstinence, a monogamous relationship with a male who has had a vasectomy, use of an IUD, a double-barrier contraceptive method (e.g., condom with spermicide, condom and diaphragm with spermicide, contraceptive implant, injectable contraceptive, or oral contraceptive).  Medically accepted methods of contraception for you and/or your partner will be defined in detail at screening.

• If Female and not capable of becoming pregnant, I have been postmenopausal for at least 12 months, or, I have been surgically sterile (ovaries removed, tubes tied, uterus removed) for at least 6 months   

• If Male, I agree to practice a method of medically approved contraception which includes abstinence, a monogamous relationship with a female who is not capable of becoming pregnant, a vasectomy, or the use of condoms throughout the study and for 30 days after receiving the study drug

• I have not had any significant changes, nor do I anticipate changes, to prescription or nonprescription medication used to manage an underlying condition within 60 days prior to Day 1

• I am not currently taking nor have I received systemic biologics 6 months prior to Day 1

• I have not taken, nor am I taking, an immunomodulatory or immune suppressing medical treatment (e.g., azathioprine, methotrexate) during the 2 months prior to screening

• I am not taking immunosuppressive doses of corticosteroids daily, or on alternative days for 2+ weeks, within 6 months prior to the first dose of study drug

   

• I do not have a history of hypersensitivity (e.g., of anaphylaxis, angioedema, atopic dermatitis, or urticarial) or severe allergic reaction (any reaction that resulted in hospitalization), congenital anomaly, or disability, that requires medical intervention to prevent permanent impairment or damage to any other allergens (including medications, food or environmental)

   

• I do not have any untreated or active gastrointestinal disease (e.g., peptic ulcer disease, esophagitis, irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis)

   

• I have not had an acute illness including fever (> 100.4 degrees), within 28 days of check-in for Day -1

• I have not had an active malignancy, history of malignancy or chemotherapy, within the past 5 years (NOTE: other than past history of localized or surgical removal of basal cell skin cancer, cervical cancer in situ treated successfully, or by hysterectomy)

• I do not have a history of any drug or alcohol abuse within the past 5 years, or alcohol consumption greater than 21 units per week.A unit of alcohol is equivalent to: 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits/hard liquor.) (NOTE: Alcohol consumption will be prohibited prior to check-in at the clinical research unit on Day 1 and throughout the study.)

• I do not have a history or presence of any eating disorder

   

• I have not received a live vaccine (within 28 days) prior, or a subunit vaccine (within 14 days) prior to first dosing/Day 1 and I do not plan to have a vaccination during the study

• I have not donated blood or plasma ≤ 56 days prior to Screening and I do not plan to donate blood or plasma within 5 weeks of completing the study

   

• I have not received blood products, monoclonal antibody, or other systemic protein therapy within 6 months prior to first dosing/Day 1 (NOTE: Oral protein supplements are permitted.)

• I am able to communicate effectively in English with the study personnel

   

• I do not have a history of any severe or life-threatening allergies (e.g., food or drugs or latex)

• I tolerate oral medication well

• I have not had problems having blood drawn in either arm, venous access or finger pricks.

Qualified Participants May Receive:

Qualified participants may be compensated up to $3,000 for time and travel.