ICON Early Phase Services is conducting a research study for healthy non-smoking Adults ages 18-55. The purpose of this study is to evaluate the safety and tolerability of an investigational drug to treat autoimmune diseases. You will be given the study drug 1 time by subcutaneous injection (under the skin).
Study for healthy non-smoking Adults ages 18-55 XE 2281-0130
Vital signs, ECGs, physical examinations, drug and alcohol testing will be performed. Blood, nasopharyngeal swabs and urine samples will also be obtained during this study.
Participants will complete:
• screening visits (COVID-19 testing on a separate day)
• 4 consecutive overnights (admit day -1 and discharge Day 4)
• 8 Outpatient visits (Days 6, 8,10,12, 15, 18, 21 and 30)
Patients with low white blood cells at Day 30 may be asked to return on Day 58 for additional lab tests
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 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 55 years old
• My Body Mass Index (BMI) is between 19.0 and 35.0 kg/m2 and my weight is between 110 and 220 pounds
*Note Cohort 1 participants must weigh between 187 and 220 Pounds
• I have not received a clinical study drug within 5 half-lives (how long it takes for half of the dose of previous study drug to be eliminated from the bloodstream) prior to dosing and agree to not participate in another investigational drug or device study during this study
If Female, I meet one of the following:
• Postmenopausal (no menses for 12 months)
• Surgically sterile (documented hysterectomy, bilateral tubal ligation or bilateral oophorectomy)
• Child bearing and currently use one of the following and agree to continue use for 30 days after the last dose of study drug-
• Combined hormonal contraceptives or Progestin only (oral, intravaginal, transdermal, injectable or intrauterine)
• IUD (with or without hormonal releasing system)
• Bilateral tubal occlusion
• Sterilized male partner (with documentation)
• Sexual abstinence
If Male, I agree to refrain from sperm donation during the study and for 30 days after the last dose of study drug and use one of the following during the study and for 30 days following the last dose of study drug:
• Vasectomy (records required)
• Condom in combination double-barrier methods, spermicide, hormonal birth control, or IUD (non-hormonal) used by the female partner
• I have suitable veins for multiple blood samples
• I am able to communicate effectively in English with the study personnel
• 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 of Clinical Site
8307 Gault Lane, San Antonio, TX, USA