Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test a potential treatment for autoimmune diseases. The study drugs will be dosed orally.
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
- 32 consecutive overnights
- 1 outpatient visit
- 2 follow-up phone calls
To determine if you fully qualify, it will be necessary to obtain blood samples after a recommended 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 55 (inclusive) years old
- My BMI is between 18.0 and 30.0 (inclusive) kg/m2 and I weigh at least 110 lbs.
- I am a non-smoker and agree to not smoke for the duration of the study. I have not used tobacco or nicotine-containing products, vape, or marijuana-containing products within the past 3 months.
- I have not received any investigational drug in a clinical trial within 30 days prior to first dose
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control during the study and until completion of the 75-day follow-up. Acceptable methods of birth control include:
- Combined (estrogen and progestogen containing) hormonal contraception which can be oral, an implant or transdermal
- Progesterone-only hormonal contraceptives (oral, injectable, implantable)
- Hormone-releasing IUD or hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 2 years or I am surgically sterile (tubes tied, ovaries removed, uterus removed)
- If Male and I have a partner capable of becoming pregnant, I agree to use a latex condom with spermicide while participating in the study until completion of the 75-day follow-up
- If Male, I agree to refrain from donating sperm during the study until 75 days after the last dose of study drug
- I am able to communicate effectively in English with the study personnel
- I do not have any heart disease
- I do not have a recent history of alcoholism, drug abuse or addiction
- I agree to report all medications (including over the counter, dietary, herbal supplements, prescription medications and hormonal contraceptives) I take regularly or occasionally
- I have not donated blood within 60 days prior to first dose
- I am able to refrain from consuming alcohol until the last follow-up
- I am able to consume standardized meals.
Qualified Participants May Receive:
Qualified participants may be compensated up to $10,000 for time and travel.