Summary:
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
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. 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 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), bilateral tubal ligation or occlusion, bilateral salpingectomy, 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 produce (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 had 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
Qualified Participants May Receive:
Qualified participants may be compensated up to $4,200 for time and travel