Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT03621605
Eligibility Criteria:
Key Inclusion Criteria:
1. Healthy male and female subjects aged 18 through 65 years at the time of consent.
2. Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg.
3. Females must have been surgically sterilized.
4. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through to the final follow-up visit.
5. Able and willing to comply with the requirements of the protocol.
Key Exclusion Criteria:
1. Concurrent enrollment in another clinical study involving an investigational treatment.
2. Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1).
3. Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
4. History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening.
5. Positive test for drugs of abuse.
6. Donation of blood or blood products in excess of 500 mL within 3 months prior to screening. Not agreeing to refrain from blood or blood product donations during study participation.
7. Receiving any of the prohibited concomitant medications:
1. Any immunotherapy or immunosuppressive therapy
2. Chronic use of steroid medications
3. Immunoglobulin or blood products
4. Live vaccines
5. Anticoagulants
6. Aspirin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03621605
Study Brief:
Protocol Section:
NCT03621605