Last updated on May 2018

Healthy RE 3877-0004

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: *Healthy Patient Studies
  • Age: Between 18 - 55 Years
  • Gender: Male or Female

To determine if you fully qualify, it will be necessary to obtain blood samples after a 10- hour fast[f1] . You have the option of fasting for the screening appointment, or, you may return at a later date. You may need to provide medical records to participate in this study. For more information, see below.

Qualified participants may be compensated up to $4,300 for time and travel. 

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 years old.
  • My BMI is between ≥ 18.0 and ≤ 32.0 kg/m2  and I weigh between 99 lbs. and 220 lbs. inclusive. 
  • I am a non-smoker and I have not used any tobacco or nicotine-containing products within 3 months prior to dosing. 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 participated in another clinical trial and/or been exposed to any investigational drug or device, or approved therapy for investigational use, within 28 days of first dose.
  • If Female, I am not capable of becoming pregnant and I have been postmenopausal for at least 12 months or I am surgically sterile (ovaries removed, uterus removed) or I have medically confirmed ovarian failure. Please bring documentation to screening if possible.    
  • If Male, I agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond dosing of study drug. (NOTE: No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non‑vasectomized male.  
  • If Male, I agree not to donate sperm from dosing until 90 days after receiving last dose. 
  • If Male, I am not planning a pregnancy with my partner within 90 days after dosing of study drug.
  • I am able to communicate effectively in English with the study personnel. 
  • I do not have tattoos or scarring on or near the abdominal site of the subcutaneous injection.
  • I do not have a history of any malignancy, including any cancer, with the exception of local cervical cancer (treated with hysterectomy) and successfully treated skin cancers such as squamous or basal cell carcinoma.
  • I do not have a history or presence of an infection caused by bacteria, viruses, fungi, or protozoa. 
  • I do not have a history or presence of any clinically significant local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
  • I have not had fever, or a viral or bacterial infection within 14 days prior to screening, at screening, at Day -1 check-in, or at Day 1 dosing.
  • I have not had treatment with any monoclonal antibody within 3 months prior to dosing.   
  • I do not have a history or presence of alcohol or drug abusewithin the past 2 years prior to screening. 
  • I am able to refrain from using any drug, including prescription and non‑prescription medications and herbal remedies, from 14 days prior to dosing until completion of end‑of‑study procedures. (NOTE: Acetaminophen (up to 2 g per 24‑hour period) may be permitted during the study.)
  • I have not been on a specialized or restrictive diet (vegan, vegetarian, gluten-free, etc.) within the 28 days prior to dosing and throughout the study.
  • I have not donated blood, or had significant blood loss, within 56 days prior to dosing.
  • I have not donated plasma within 7 days prior to dosing.
  • I have not had any major surgical procedure within 3 months prior to dosing (NOTE: Excluding minor cosmetic surgery or minor dental procedures.)
  • I tolerate oral medication well.
  • I have not had problems having blood drawn in either arm, venous access or finger pricks.

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. Frequently, subjects do not qualify because of medical history or minor changes in vital signs, ECG and lab tests. 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 a 10-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. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 10 hours before your appointment. We will be testing for tobacco and drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. 

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 filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.

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. 
  • All physical, occupational and rehab requests, consultations and progress notes.
  • All laboratory, histology, cytology, pathology and radiology records, results and reports.
  • All pharmacy/prescription records.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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