Additional Notes:

      *Abdominal (stomach) skin will be evaluated for any potential interference with a skin assessment. This includes large scars, large tattoos, skin conditions and darker skin tones where a skin reaction is redness, could not be easily seen.

   * A person with a Fitzpatrick skin tone scale rating of # 5 or 6 will not qualify. This is generally defined as " Naturally brown skin, brown eyes and dark hair. Burns only with excessive exposure to sun. Skin easily darkens further'  or  "Black skin with dark brown eyes and black hair. Burns only with extreme exposure to the sun. Skin very easily darkens futher."

   * If you dosed for RE 3877-0004 or RE 3877-0006, you cannot do this study.

    *Females with tubal ligation or salpingectomy will NOT qualify.

    *  Compensation in multiple payments.

                 ___________________________________________________

Healthy RE 3877-0007

San Antonio - Texas

ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test a treatment for ADPKD (autosomal polycystic kidney disease).  The study drugs will be administered by subcutaneous injection. 

 

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
  • 6 overnights (over 4 periods)
  • 7 outpatient visits

 

To determine if you fully qualify, it will be necessary to obtain blood samples after a 10- 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.

 

Qualified participants may be compensated up to $5,700 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 ≥ 17.5 and ≤ 30.5 kg/m2 at screening

 

  • I do not smoke and I have not used any nicotine containing products for at least 90 days prior to check-in. 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 an investigational product or any experimental therapeutic procedure within 28 days of Day 1

 

  • If Female and of non-childbearing status, I am either postmenopausal (for at least 12 consecutive months), or, surgically sterile (hysterectomy or both ovaries removed), or, I have medically confirmed ovarian failure.  Medical records are required for this study. 

 

  • If Male and of childbearing potential and sexually active, I agree to use a highly effective method of contraception consistently and correctly for the duration of the active treatment period and for 7 days after last dose. Highly effective methods of contraception such as hormonal methods of contraception (e.g., oral, inserted, injected, implanted or transdermal), IUD, male condom or female condom used in combination with a spermicide product (i.e., foam, gel, film, cream, or suppository), vasectomy or abstinence.

 

  • If Male, I am not planning a pregnancy with a partner in the next 90 days and I agree not to donate sperm for at least 90 days after last dose

 

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

 

  • I do not have a known active infection

 

  • I do not have a history of substance abuse with the past 2 years prior to screening

 

  • I have not had any clinically significant local or systemic infection in the 90 days prior to Day 1

 

  • I do not have a history of active malignancy within five years of Day 1, except adequately treated basal cell or squamous cell carcinoma of the skin

 

  • I have not has a significant blood loss or blood donation within 56 days prior to Day 1 or plasma donation within 7 days prior to Day 1

 

  • I do not have a tattoo or scarring on the abdomen or any other physical trait that would interfere with the ability to assess reactions at the injection site

 

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, military ID, state issued ID card, or passport.  You will be required to show this same phot ID at all study visits.

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, fact 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.

 

If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:

 

                  Click Here to Make an Appointment for RE 3877-0007

                            *Compensation in multiple payments.

 

    _______________________________________________________

      Study Dates- Note: All dates and times are tenative and may change.

            Cohort 2   

                  1st Admit Feb.12, 2020 Wed - Discharge Feb. 15 2020 Sat

                         Outpatient Visit: Feb 20, 2020 Thur

                   2nd Admit: Feb. 27, 2020 Thur - Discharge Feb. 28 2020 Fri

                   3rd Admit: Mar. 12, 2020 Thur- Discharge: Mar 13, 2020 Fri

                   4th Admit: Mar. 26, 2020 Thur- Discharge: Mar 27, 2020 Fri

                          Outpatient Visits: Apr 02 Thur, Apr 09 Thur, Apr 23 Thur, May 7, Thur                                                          May 21, Thur

                     Final Outpatient Visit: Jun 4, 2020 Thur

 

Notice:

 

In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database.  Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.  It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed.  You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.  

 

PURSUANT TO SECTION 30.06,
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN)
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.

 

Reference RE 3877-0007
Name
Details Healthy RE 3877-0007 - Females must be non-childbearing. You cannot have a Fitzpatrick skin tone of #5 or 6. You cannot do this study if you dosed for RE 3877-0004 or -0006. $100 Refer A Friend
Gender Male or Female
Dates -
Payment amount up to $5,700
Age 18 - 55

Check your BMI

Check your BMI here with our body mass calculator.

Units:
Your Height:
(cm)
Your Weight:
(kg)
Your Height:
Your Weight:
lbs
Referral Opportunities

Check out our Referral Opportunities

Referral Opportunities