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 either an Intranasal dose or an Intramuscular dose at each period.
Or call 210-225-5437 for more information
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
- 5 non-consecutive overnights (5 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 $4,850 (paid in 2 payments) for time and travel.
STUDY DATES - Note: All dates and times are tentative.
* The 1st cohort is filled before patients are placed
in the next cohort.
|Cohort 8||Cohort 9|
|1st admit||May 24, 2021||Jun 04, 2021|
|Discharge||May 25||Jun 05|
|2nd admit||May 28, 2021||Jun 08, 2021|
Discharge - 1st payment within 10 buisness
days after complete visit
|May 29||Jun 09|
|3rd admit||Jun 01, 2021||Jun 12, 2021|
|Discharge||Jun 02||Jun 13|
|4th admit||Jun 05, 2021||Jun 16, 2021|
|Discharge||Jun 06||Jun 17|
|5th Admit||Jun 09, 2021||Jun 20, 2021|
|Discharge||Jun 10||Jun 21|
End of Study Visit - 2nd payment within
10 business days after complete visit
|Jun 24||Jul 05|
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 - New dates
- Male or Female
- Payment amount
- up to $4,850
- 18 - 50