Summary:
ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test an investigational drug for the treatment of polycystic kidney disease. The study drug 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
- 3 consecutive overnights
- 10 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. You may need to provide medical records to participate in this study. 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 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.
Qualified Participants May Receive:
Qualified participants may be compensated up to $3,300 for time and travel.