RE 3877-0009

Stipend and Dates

Up to $4,340. (Multiple payments)

 

Note: You cannot pick which cohort you go into. The 1st cohort is filled before patients are placed in the next cohort. You must be able to do either set of dates.	Cohort 1B
Admit:	Jun 13, 2022 Mon
*Holter monitoring starts Day 1 to Day 2 (No electronics or cell phones)
Discharge (in afternoon) 1 or 2- Based on dosing level	Jun 15, 2022
Day 8: Outpatient Visit - (a payment within 10 business days after completion)	Jun 21
Day 15: Outpatient Visit	Jun 28
Day 22: Outpatient Visit	Jul 05
Day 29: End of Study Visit - (a payment within 10 business days after completion)	Jul 12, 2022

                          

Outpatient Dates

Click here to make an appointment for RE 3877-0009

Or call 210-225-5437 for more information

Study Criteria

Healthy non-smoking Males and Females

Age:  18-55

BMI and Weight:  18 to 35 kg/m2

GFR: greater than or equal to than 90

Study Information

Indication: The investigational drug is being developed as a potential treatment for ADPKD (Autosomal Dominant Polycystic Kidney Disease).

Route of Administration: Subcutaneous Injection (under the skin)

Washout from previous study: Has taken other investigational drugs or participated in any clinical study within 28 days prior to the first dose in this study or currently participating in another clinical study.  

Acceptable Birth Control for Females (if Childbearing):  Females of child bearing potential must agree to use a highly effective method of contraception from screening through 28 days after the final dose of the investigation drug. Highly effective methods of contraception are listed below:

• Intrauterine device
• Intrauterine system
• Partner has had a Vasectomy (at least 6 months or more prior to randomization)
• Stable Hormonal contraception with approved oral, transdermal, or depot regimen.

Females in the following categories are considered non-childbearing:

• Documented hysterectomy (removal of uterus), bilateral salpingectomy (removal of both Fallopian tubes), bilateral tubal occlusion or bilateral oophorectomy (removal of both ovaries)
• Menopause more than one year prior to study entry (stopped having monthly menstrual periods more than one year ago).

 

Acceptable Birth Control for Males: Males must agree to use condoms with spermicide or abstain from sexual intercourse from Day 1 until 28 days after the final dose. No restrictions for a vasectomized heterosexual male if vasectomy was performed 6 months or more prior to Day 1.

Male and female subjects must agree not to donate sperm or preserve eggs (ova), respectively, from Day 1 until 28 days after the administration of study drug.   

 

Study Reminders

• 10 hours fasting is required for lab work (only water is allowed)
• If taking medications, bring them to your screening appointment (including prescription, over the counter, herbal supplements and vitamins)
• Bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a valid government issued identification card such as a driver's license, state issued ID card or passport.  You will be required to show this same photo ID at all study visits
• Arrive 30 minutes before your appointment to complete paper work.