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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