Expired Study
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Clinical Trial 42869

San Antonio, TX 78209


Study Summary:

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. 

 

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 dos
  • 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.  


Qualified Participants May Receive:

Qualified participants may be compensated up to $3,300 for time and travel.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.