Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test an investigational drug to treat eosinophilic esophagitis (which affects the lining of the esophagus). The study drug will be administered intravenously or by subcutaneous 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
- 5 consecutive overnights
- 8 outpatient visits
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 a healthy adult, meaning no significant medical conditions
- I am between 18 and 55 years old
- My BMI is between ≥ 18.0 and ≤ 30.0 kg/m2 and I weigh at least 88 lbs.
- I am a non-smoker. 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 any investigational drug within 30 days prior to screening
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use a highly effective method of contraception throughout the study and for 5 months after last dose. Acceptable methods of birth control in this study are:
- combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable or implantable
- placement of an intrauterine device or intrauterine hormone-releasing system
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence.
- If Female and not capable of becoming pregnant, I am postmenopausal (for at least 2 years) or I am surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy at least 6 months before screening). Please bring medical records to screening.
- If Male, I agree to use a latex condom during sexual contact with women of child-bearing potential (WOCBP) while participating in the study until 5 months after last dose
- If Male, I agree to refrain from donating sperm during the study until 5 months after last dose
- All subjects: Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- I am willing to refrain from all alcohol consumption for 48 hours prior to Day 1, during confinement to the CRU, and to limit the intake of alcohol to no more than 2 units per day throughout the study. One unit of alcohol is defined as 8 g (10 mL) of absolute alcohol. This is the approximate amount in a 1/2 pint (300 mL) of beer, a single measure of spirit (25 mL), or a single glass of wine (100 mL).
- I am able to communicate effectively in English with the study personnel
- I do not have a history of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease
- I do not have a history of cancer or lymphoproliferative disease within 10 years of screening (other than a successfully treated non‑metastatic cutaneous squamous cell or basal cell carcinoma, or adequately treated cervical carcinoma in situ)
- I do not have a history of infection within 30 days of dosing on Day 1
- I have not had systemic or diarrheal illness following travel or residence in endemic areas of parasitic/helminthic infections, history of clinical schistosomiasis, and a history of travel to endemic areas within preceding 6 months
- I do not have a history of alcohol or drug abuse, or addiction, within 6 months prior to screening
- I do not have a history of tuberculosis, listeriosis, or untreated parasitic infections
- I have not received any drug by injection within 30 days of Day 1
- I agree to abstain from strenuous physical activities for at least 24 hours prior to dosing (Day 1) and throughout the study
- I do not have tattoos or other skin markings (e.g., scarring) that would prevent visualization (abdomen or the IV infusion area) of potential rashes due to study treatment. (NOTE: If you have more than 25% of your body tattooed you may be disqualified.)
- I have not donated blood within 60 days prior to Day 1 and I agree not to donate blood while on study
- I do not have a history of any severe or life-threatening allergic reactions to any drug, biologic, food, vaccine 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 $3,800 for time and travel.