Healthy SA 3112-0117
ICON Early Phase Services is conducting a research study for healthy adults ages 18-45. This study is being done to test a potential treatment for fungal infections.
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
- 7 consecutive overnights
- 2 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- 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 $3,300 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 45 (inclusive) years old
- My BMI is between 18.5 and 35.0 kg/m2 (inclusive) and I weigh at least 110 lbs.
- I do not use any nicotine or tobacco-containing products and I have not used any of these products recently. I agree not to use any of these products 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 any clinical research study with this drug
- I have not had any investigational product or treatments within 28 days prior to dosing
- NOTE: Dosing will be in the lower abdomen and we will be monitoring the injection site closely for any reaction. Please see the criteria below.
- I do not have any tattoos, piercings or dark birthmarks on my lower abdomen
- If Female, I am not pregnant or breastfeeding and I do not plan to become pregnant during the study or for 4 months after last dose
- If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control. The allowable methods of birth control include:
- surgical sterilization by tubal ligation
- progestin-releasing subdermal implants (e.g., Nexplanon and Implanon)
- copper intrauterine devices/IUDs (e.g., ParaGard)
- levonorgestrel-releasing/IUDs (e.g., Mirena, Skyla, Liletta)
NOTE: Allowable methods of birth control must already be in use prior to dosing and maintained for at least 4 months after last dose.
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 12 months or I am surgically sterile (hysterectomy, ovaries removed, tubes removed). Documentation is required.
- If Male and I have not had a vasectomy, I agree to use barrier contraception (condom and spermicide) from first dose until 18 weeks following last dose
- If Male, I agree not to donate sperm from first dose until 18 weeks following last dose
- I am able to communicate effectively in English with the study personnel
- I am in good health and I have not recently been diagnosed with an ongoing medical condition
- I have not recently donated blood or blood products or experienced significant blood loss
- I have not recently had a blood transfusion
- I do not have a history of hypersensitivity or allergic reactions
- I am not currently experiencing symptoms of acute illness or chronic disease
- I do not have a history of illicit/illegal drug use
- I have not had a recent problem with alcohol abuse or substance abuse
- I am willing to refrain from taking over-the-counter or prescription medications, vitamins, or herbal and nutritional supplements. NOTE: Hormonal contraceptives, acetaminophen and ibuprofen are acceptable.
- I have not recently received any live or inactive vaccines
- I am willing to refrain from strenuous physical activity (e.g., contact sports) from screening until completion of the trial
- I have not had problems having blood drawn in either arm.
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. 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 an 8-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 8 hours before your appointment. We will be testing for tobacco use 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 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, military ID or passport. You will be required to show this same photo 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, 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.
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: