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  • Study 1415: Healthy Male and Female Particpants

    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:

    Males

    Men are allowed to participate

    Females

    Women are allowed to participate

    Age

    18-45 years

    Body Mass Index (BMI)

    19 and 30.5

    Weight

    Greater than 132 pounds

    Tobacco/Nicotine Use

    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.

    Drug Testing

    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.

    Health History

    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

    Restricted Medications

    No required regular use of any prescription medications, non-prescription medications, vitamins, or herbal supplements not listed below

    Allowed Medications

    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. 

    Inpatient Stays

    • Participants will admit for an inpatient stay at Prism Clinical Research 1 time.
    • The inpatient stay will last approximately 8 ½ days (8 overnights)

    Outpatient Visits

    • There are at total of 9 outpatient visits
    • The outpatient visits will last between approximately 1-2 hours

     Compensation: Up to $2950.00

Where hope, science & understanding meet.

From the aspirin on the shelves of your local drugstore, to the insulin prescribed by a doctor, to the pacemaker keeping someone’s heart on track – all have been subject to clinical trials, and integral part of the Food and Drug Administration (FDA) approval process.

A critical step in an important process

Drugs and medical devices undergo years of laboratory testing before they reach the clinical trial phase. Researchers must acquire approval from the FDA for approval to continue research and testing in humans. Clinical trials are essential to measure the efficacy and safety of drugs before they are available for widespread use.

Changing lives, every day.

The impact of clinical trials are seen in our everyday lives, in the confidence with which we can take over-the-counter drugs – or in the life-saving benefits of a breakthrough medication for a victim of Leukemia.

Public Health and Safety

Prior to the development of the FDA’s rigorous and highly regulated method, consumers had to rely upon the anecdotal observation of physicians or spurious claims of pharmacists. In 1906, in order to protect public health and safety, the fledgling FDA passed the first regulatory drug act – the Pure Food and Drug Act.

In 1938, the enactment of the U.S. Food, Drug, and Cosmetic Act subjected new drugs to pre-market safety evaluation for the first time, thus enabling FDA regulators to review both pre-clinical and clinical test results, giving them the authority to block the marketing of a new drug formally or delay it by requiring additional data.

Alongside the evolving standards of drug regulations, closer regulation of the clinical trial process. The resulting process today is designed to protect the safety of study participants, promote the development of lifesaving drugs, and keep public health and safety at the center of medical advancement. In the century since the first drug act, the research and medical community in cooperation with the FDA, have developed the foremost institutional authority for conducting and evaluating controlled clinical drug trials.

Doing the right thing

Know that you’ve done your part to help make important medications available to those who need them. If you have a friend or family member who relies on a medication to treat a chronic disease or illness, they have benefited from the work of a clinical trial, and a volunteer like you who gave their time and effort to aid in the approval process.

Fair compensation for your time

You’ll be compensated based on the time you spend as a study participant.

Medical exam & monitoring

As a study participant, you’ll likely receive a full medical examination and testing for a variety of conditions. In some cases volunteers might have access to treatments or medicines before they are available to the general population.

Changing lives, advancing science, furthering the reach of medicine.

Prism Clinical Research provides, FDA approved, investigational pharmaceutical and medical device testing services on behalf of drug and device manufacturers, academic and private physicians as well as other researchers across Minnesota.

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At Prism, we are committed to the advancement of medical knowledge and the health of our community. We have been conducting Phase I clinical trials since 2005, helping many important drugs reach FDA approval. Prism is a locally owned and operated, independent facility in the heart of the Minneapolis/St. Paul metropolitan area. 

Whether you are here because you are interested in participating in a clinical trial, or you’re searching for a trusted partner to conduct a study on your behalf, our hope is that you find the information you need and the confidence to take the next step. 

With your help, we can make a difference.


Learn what Prism Volunteers are saying:

Volunteer Large 13

"I am VERY pleased with Prism Research. I enjoy the studies and the staff is always friendly and they all make you feel as comfortable as possible. The study compensation program is very good as well! Thank you."

  • Volunteers 08

    “Concerned enough to ask questions. I enjoy visiting with the staff. I look forward to future studies and may qualify to participate in.”

  • Volunteers 05

    “Overall you do a great job! Your staff is very friendly and accommodating. Your facility is very comfortable. Thanks!”

  • Volunteers 06

    “Staff was courteous and well informed of the nature of the study and all of the requirements that went with it.”

  • Volunteers 07

     “Overall my experiences at Prism have been very positive and directly linked to the Staff - their demeanor, humor and professional approach.”


Please provide us with your contact information (below) and will get back to you as soon as possible.

If you have a general question, check Volunteer FAQ for an answer. If you're unsure of who to contact, please visit the Contact Us page.

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