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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT04187560
Eligibility Criteria:
Inclusion Criteria:
Subjects may be included in the study only if they meet all of the following criteria:
1. Competent to provide informed consent.
2. Voluntarily provide informed consent.
3. Healthy adult male and female subjects between 18 to 55 years of age inclusive at the screening visit.
4. Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 at screening visit.
5. Subjects must be in good general health as determined by medical history and physical examination with no clinically significant medical findings and no history of significant medical disease (e.g. cardiovascular, pulmonary, renal, etc.) or acute condition with the past 30 days.
6. Have normal clinical laboratory test results and ECG, which are not considered to be clinically significant by the investigator.
7. Female subjects of child-bearing potential must agree to use two methods of an acceptable method of birth control (e.g., condom and spermicide, intrauterine device (IUD), oral contraception which has been stable for 30 days) and at least 90 days after stopping the investigational product. Female subjects using oral contraception whose partner consistently uses condoms or who is vasectomized is also acceptable.
8. Male subjects must be surgically sterile or practicing at least one method of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug:
9. Male subjects must agree to abstain from sperm donation through 90 days after administration of the last dose of investigational drug.
Exclusion Criteria:
Subjects will be excluded from the study for any of the following reasons:
1. Are pregnant or lactating.
2. Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures.
3. Clinically significant abnormal findings on physical examination, vital signs, or ECG.
4. History or presence of psychiatric or neurological disease or condition.
5. History of seizures.
6. Subject with any history or current evidence of suicidal behavior.
7. Unwilling to complete any planned study assessments, including the Columbia-Suicide Severity Rating Scale (CSSRS).
8. Recent history of alcohol or drug abuse (within the last two years).
9. Any use of tobacco or tobacco-containing products (cigarettes, pipes, etc.) within one month prior to screening.
10. Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Screening.
11. Have received treatment with an investigational drug or device within 30 days prior to Screening.
12. Use of any prescription or over the counter medication, herbal medications, vitamins, or supplements within 14 days prior to study drug administration.
13. Have a positive test for human immunodeficiency virus (HIV) antibodies 1 and 2, Hepatitis B surface antigen or Hepatitis C antibody.
14. Any subject who is known to be allergic to the study drug or any components of the study drug.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04187560
Study Brief:
Protocol Section:
NCT04187560