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Research Purpose: Study 1321 is designed to evaluate an investigational drug being developed for the treatment of certain types of inflammatory disorders. The investigational drug will be given orally to healthy participants. The purpose of the study is to determine how much of the investigational drug enters the blood stream when given at different dose levels; whether having an empty or full stomach affects how much of the investigational drug enters the blood stream; and how well the body tolerates the investigational drug.
Screening Qualifications: Participants must meet the following minimum criteria in order to qualify for a screening appointment:
- Age 18-55 years
- Body Mass Index (BMI) between 18-32
- Must be healthy; not being evaluated or treated for any medical conditions.
- Cannot take medications on a regular basis (Exception: women can be using an prescribed hormonal birth control)
- No history of cancer (Exception: cured basal or squamous cell skin cancers)
- No history of drug addiction or alcoholism 12 months prior to the screening appointment
- No use of more than the equivalent of 5 cigarettes per week in the two months before the screening appointment.
- Must be able and willing to refrain from use of tobacco or nicotine containing products one week before the study starts until the end of the study
- Must be able and willing to eat/drink a study specific meal which includes pork, eggs, dairy, and gluten.
Study Time Commitment: For participants who qualify for the study based on screening results, study participation will last for approximately 3 ½ weeks. During that time, participants will stay at Prism Clinical Research for three short inpatient stays lasting approximately 72 hours (three overnights) each time. The inpatient stays will be separated by one week. There will be one brief outpatient visit following the final inpatient stay.
Compensation: up to $2550 for participation time
Research Purpose: Study 1415 is designed to evaluate an investigational drug being developed for the treatment of certain types of inflammatory conditions. A single dose of the investigational drug will be given as a subcutaneous injection (just under the skin) and will be compared to similar versions of the drug which are approved to be prescribed in the U.S. and Europe (adalimumab/Humira®). The following will be evaluated:
- How quickly the body process and eliminates the investigational drug compared to the U.S and E.U. approved versions
- The safety/tolerability of the investigational drug compared to the U.S and E.U. approved versions
- The body’s immune response to the investigational drug compared to the U.S and E.U. approved versions
Minimum Screening Qualifications:
Men are allowed to participate
Women are allowed to participate
Body Mass Index (BMI)
19 and 30.5
Greater than 132 pounds
No tobacco/nicotine 24 hours prior to in-house stay or while at the research unit. Use of tobacco/nicotine products at all other times during the study is allowed.
Must test negative for drugs of abuse.
Alcohol/Drug Abuse History
No history of drug or alcohol abuse within 5 year of the screening appointment.
Must be healthy; not being evaluated or treated for any medical conditions unless otherwise approved on a case by case basis by the study doctor
No required regular use of any prescription medications, non-prescription medications, vitamins, or herbal supplements not listed below
Acetaminophen and prescribed/stable hormonal birth control are allowed.
Study Time Commitment: For participants who qualify based on screening evaluation, study participation will last for approximately 10 ½ weeks.
- Participants will admit for an inpatient stay at Prism Clinical Research 1 time.
- The inpatient stay will last approximately 8 ½ days (8 overnights)
- There are at total of 9 outpatient visits
- The outpatient visits will last between approximately 1-2 hours
Compensation: Up to $2950.00