ICON Early Phase Services is conducting a research study for healthy males and females ages 18 to 55. The purpose of this study is to test the safety and tolerability of a single dose of an investigational medication (will be given as an Intramuscular injection or IV infusion). The investigational medication is being investigated for the treatment and prevention of COVID-19 in adults.
Clinical trial study for healthy males and females ages 18 to 55
Vital signs, ECGs, physical examinations, pregnancy and alcohol testing will be performed. Blood/nasal swabs and urine samples will also be obtained during this study.
Participants will complete:
1 screening visit
2 consecutive overnights
11 outpatient visits
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 the screening appointment, or, you may return at a later date. 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 between the ages of 18 and 55 years of age, meaning no significant medical conditions
•My BMI is between ≥18.5 and ≤35 kg/m2
•I have not received an investigational drug within the last 28 days before dosing for this study and I do not plan to enroll in another clinical trial including a drug, biologic or device
•I have suitable veins for multiple blood samples
•If Female, I am not pregnant or breastfeeding and if able to have children, agree to use an acceptable form of contraception for the duration of the study such as Progestin implants, IUDs, surgical (hysterectomy or tubal ligation, vasectomy) or abstinence. The use of progestin injectables, combined oral hormonal contraceptives, condoms and diaphragms will only be acceptable if used in combination with another method. (For example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterilized male partner use a double-barrier methods).
•If female, I am not able to have children and meet one of the following criteria – postmenopausal or surgically sterile (defined as bilateral oophorectomy, or hysterectomy)
•If Male, I am willing to use condoms for the duration of the study
•I agree to minimize my risk of exposure to COVID-19
•I agree not to smoke while staying in the CRU and to abide by the rules of the clinic, which is a non-smoking facility
•I am able to communicate effectively in English with the study personnel
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.
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.
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.
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA