New study for celiac disease

[David Grey]

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.


8307 Gault Lane
San Antonio, TX 78209

[phone]

Sponsored By: ICON Early Phase Services
Stipend: $3000 - $3000
Length of Study: 4 weeks
Research Facility: In-Patient
Gender: Both
Age: 18 - 65
Health Condition: Celiac Disease

More Information: Vital signs, ECGs, physical examinations, Holter monitoring and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study. Please note that fingernail polish and fake nails are not allowed due to oximetry testing.

Participants in Part A will complete:
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.

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

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 nie 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 od of contraception throughout the study and for 30 days after completing the study. These ods include abstinence, a monogamous relationship with a male who has had a vasectomy, use of an IUD, a double-barrier contraceptive od (e.g., condom with spermicide, condom and diaphragm with spermicide, contraceptive implant, injectable contraceptive, or oral contraceptive). Medically accepted ods 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 od 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, otrexate) 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 dis

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.