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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT02389192
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Adult healthy volunteers 18 to 50 years of age, inclusive.
2. Able to understand and provide written informed consent.
3. Body mass index 18 kg/m2 to 29 kg/m2, inclusive, at time of screening.
4. Female subjects must be of non-childbearing potential (e.g., be confirmed postmenopausal or have undergone surgical sterilization) or must, in conjunction with their sexual partner(s), use a highly effective contraceptive (namely, a long-acting reversible method (IUD, injectable, or implant), or a combination of oral contraception in conjunction with a male condom) during the screening period and for at least 30 days after the infusion of study medication.
5. Male subjects must either be sterile or agree to use, for the entire duration of the study, a male condom; the female sexual partner must also use a medically acceptable form of birth control (e.g., oral contraceptives), or a highly effective contraceptive (as described in #4 above).
6. Male subjects must agree to not donate sperm for at least 30 days after the infusion of study medication.
EXCLUSION CRITERIA:
1. Pregnancy or breastfeeding.
2. A positive urine or blood screen for drugs of abuse at time of screening.
3. Prior use of any medical intervention involving antibody products.
4. Active substance abuse or any medical or psychiatric condition that, in the opinion of the principal investigator, could jeopardize the subject's safety or the subject's ability to comply with the protocol requirements.
5. Any chronic medical problem that requires daily medications (except Tylenol, oral contraceptives, vitamins, eye drops, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase 1 drug.
6. Allergy or intolerance of antihistamines, acetominophen, or catabolic steroids.
7. Active participation in any interventional clinical trial within 6 months prior to the dosing on Day 0 (i.e., received any other investigational drug).
8. Prolonged QTcF interval \> 440 ms for males or \> 460 ms for females.
9. Other clinically significant ECG abnormality, as determined by the principal investigator.
10. Any clinically significant abnormal hematology, chemistry, coagulation, or urinalysis value, as determined by the principal investigator.
11. Glomerular filtration rate (GFR) of \< 80 mL/min, based on the Modification of Diet in Renal Disease equation.
12. Urine-albumin-to-creatinine ratio (UACR) \> 30 mg/g.
13. Positive serology for Hepatitis B surface antigen
14. Positive serology for Anti Hepatitis C Antibody
15. Positive ELISA for HIV
16. Known or suspected exposure to Ebola virus.
17. Received investigational vaccine for prevention of EVD.
18. Received investigational treatment for EVD.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02389192
Study Brief:
Protocol Section:
NCT02389192