ICON Early Phase Services is conducting a research study for healthy non-smoking Adults ages 18-45. The purpose of this study is to evaluate the safety and effect of an investigational drug to treat moderate to severe COVID-19 infections. The study drug consists of a combination of two FDA approved drugs for use in patients with other conditions. You will be given the study drug 3 times by subcutaneous injection (under the skin).

Click here to make an appointment for ME 5753-0001

Or call 210-225-5437 for more information

Vital signs, ECGs, physical examinations, drug, tobacco and alcohol testing will be performed. Blood and urine samples will also be obtained during this study.  A chest X-Ray will be scheduled and performed at another location.

Participants will complete:

  •  Screening visit
  • 3 non-consecutive overnights
  • 2 Outpatient visits

The length of the study from the first admit to end of study is approximately 12 days.

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.   For more information, see below.

Qualified participants may be compensated up to $3,000 for time and travel.

 STUDY DATES - Note: All dates and times are tentative and may change.

  Cohort 2A
Admit 6:00 AM Feb 26, 2021 Fri
Discharge Feb 27,
Admit 6:00 Am Feb 28, 2021 Sun
Discharge Mar 01
Admit 6:00 AM Mar 2, 2021 Tue
Discharge Mar 03
Outpatient Visit Mar 04
End of Study Visit Mar 09

 

If you are able to answer “YES” to the following statements, you may qualify for this study. 

  • I am a healthy non-smoking male or female, meaning no significant medical conditions
  • I am between 18 and 45 years old
  • My BMI is  between 18.8 and 32.0 kg/m2   
  • I have not received an investigational drug within 30 days prior to screening
  • My renal function tests (GFR) are greater than 50 mL/Min
  • If Female, I meet one of the following: 
    • Postmenopausal (no menses for 12 months)
    • Surgically sterile (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy)
    • Child bearing and currently use one of the following –
      • Hormonal contraceptives
      • IUD (with or without hormonal releasing system)
      • Double barrier (condom with diaphragm or cervical cap)
      • Sterilized male partner
      • Total abstinence as a lifestyle choice
  • If Male, I agree to refrain from sperm donation and use one of the following during the study and for 8 weeks following the study:
    • Double barrier contraception and a highly effective hormonal method of contraception
    • Double barrier birth control (e.g. male condom, female condom, diaphragm, sponge, or cervical cup together with spermicidal foam, gel, film, suppository)
    • Intrauterine device
    • Total abstinence as a lifestyle choice
  • I have suitable veins for multiple blood samples
  • I am able to communicate effectively in English with the study personnel
  • I have not received a vaccination (including influenza) within the 30 days prior to the planned dose

Screening Reminders-

  • 8 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.
Name
ME 5753-0001
Details
Healthy Adults - BMI 18.8-32.0
Gender
Male or Female
Payment amount
up to $3,000
Age
18 - 45