ICON Early Phase Services is conducting a research study for healthy non-smoking adults ages 18-50. The purpose of this study is to compare the safety and tolerability of intranasal dosing of the study drug to the intramuscular injections of the FDA approved drug Epinephrine. The study drug is being developed for the treatment of severe allergic reactions. Participants will receive 2 Intranasal doses and 2 Intramuscular doses.
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Vital signs, ECGs, physical and nasal examinations, drug and alcohol testing will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- Screening visit
- 4 non-consecutive overnights (4 periods of 1 overnight each)
- Follow-up visit
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. For more information, see below.
Qualified participants may be compensated up to $4,300 (paid in 2 payments) for time and travel.
STUDY DATES - Note: All dates and times are tentative.
|Cohort 2||Cohort 3|
|1st admit||Mar 15, 2021||Mar 24, 2021|
|Discharge||Mar 16||Mar 25|
|2nd admit||Mar 19, 2021||Mar 28, 2021|
|Discharge||Mar 20||Mar 29|
|3rd admit||Mar 23, 2021||Apr 01, 2021|
|Discharge||Mar 24||Apr 02|
|4th admit||Mar 27, 2021||Apr 05, 2021|
|Discharge||Mar 28||Apr 06|
|End of Study Visit||Apr 11, 2021||Apr 20, 2021|
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy (meaning no significant medical conditions) non-smoking male or female
- I am between 18 and 50 years old
- My BMI is between 18.5 and 31.9 kg/m2
- I have not participated in a clinical study within 30 days prior to screening
- If Female, I meet one of the following:
- have been postmenopausal for more than 1 year
- agree to use an acceptable form of birth control such as -
* Surgically sterile (such as hysterectomy [removal of the uterus], bilateral oophorectomy [removal of both ovaries], bilateral tubal ligation [both tubes tied])
* Oral (by mouth) birth control pills
* Implants or injections
* Intrauterine device (IUD)
* Diaphragm or cervical cap with spermicide
* Condoms with contraceptive foam, gel, or cream
* Male partner sterility
- I have suitable veins for multiple blood samples
- 10 hours fasting is required for lab work (only water is allowed)
- If taking medications, bring them to your screening appointment.
- 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.
- Arrive 30 minutes before your appointment to complete paper work.
- AM 2461-0003
- Healthy Adults - Partial payment available
- Male or Female
- Payment amount
- up to $4,300
- 18 - 50