Expired Study
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Clinical Trial 39599

San Antonio, TX 78209


Study 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 and inflammatory diseases.   

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
  •  3 consecutive overnights
  •  8 outpatient visits

To determine if you fully qualify, it will be necessary to obtain blood samples after an 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 32.0 kg/m2  and  I weigh at least 99 lbs.

 

  • 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 or experimental procedure  in a clinical trial within 90 days prior to first dose

 

  • My skin color is not a Type 5 (sun insensitive skin, rarely burns, tans well) or Type 6 (sun insensitive, never burns, deeply pigmented) on the Fitzpatrick skin type scale

 

  • 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 for a period of 20 weeks after their last dose.  Methods of birth control include: 
    • Combined (estrogen- and progesterone-containing) hormonal contraception (oral, implant, injectable) for at least 30 days
    • Progesterone-only hormonal contraceptives (oral, implant, injectable)
    • Progesterone-releasing IUD
    • Vasectomized partner
    • Heterosexual abstinence if this is the preferred and usual lifestyle

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 1 year or I am surgically sterile (tubes tied, uterus removed, tubes removed) or I was born sterile.   

 

  • I am able to communicate effectively in English with the study personnel.

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  Additionally, no guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

To determine if you fully qualify, it will be necessary to obtain blood and urine  samples after an 8-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID and your Social Security Card with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, or passport.  Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records.  You will be required to show this same photo ID at all study visits.

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports.  You will not be allowed to participate in the study without medical records defined as:

  • All medical records, including but not limited to: office notes, face sheets, history and physical, consultation notes, inpatient, outpatient and emergency room treatment, all clinical charts, reports, surgical reports, order sheets, progress notes, nurse's notes, social worker records, clinic records, treatment plans, admission records, discharge summaries, reports of consultations, documents, correspondence, test results, statements, questionnaires/histories, from your medical provider(s).
  • For females, surgical reports are required as documentation for procedures such as hysterectomy, bilateral oophorectomy and tubal ligation. 


Qualified Participants May Receive:

Qualified participants may be compensated up to $4,500 for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.