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 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT03776695
Eligibility Criteria:
Inclusion Criteria:
1. Adult volunteers, aged 21 to 60, men or women
a. Women must fulfil one (1) of the following criteria: i. Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone \> 40 mIU/mL ii. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation iii. Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening day until 100 days post-infusion b. Male subjects who are non-vasectomized (or vasectomized less than six (6) months prior to dosing) and have female partners of childbearing potential must be willing to use an effective birth control method when having heterosexual intercourse, from screening day until 100 days post-infusion
2. Any one or a combination of symptoms and signs suggestive of ZIKV acute infection, presenting within 48 hours from onset
3. Positive ZIKV PCR for acute ZIKV infection
4. Subjects who are willing to comply with the requirements of the study protocol and attend scheduled visit
5. Subjects who give written informed consent approved by the Ethical Review Board governing the site
6. Satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that are acceptable for study entry
7. Accessible vein in the forearm for blood collection
Exclusion Criteria:
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, or immunosuppressive disorders
2. Evidence of clinically significant anaemia (HB \< 10 g/dL) or any other significant active haematological disease, or having donated \> 450 mL of blood within the past three (3) months
3. Evidence of substance abuse, or previous substance abuse
4. Participation or planned participation in a study involving the administration of an investigational compound within the past four (4) months or during this study period
5. Planned administration of any vaccine not foreseen by the study protocol 12 weeks before first dosing day and up to four (4) months after dosing
6. Receipt of immunoglobulins and/or any blood products within nine (9) months of study enrolment or planned administration of any of these products during the study period
7. History of any reaction to monoclonal antibodies
8. Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception
9. Any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT03776695
Study Brief:
Protocol Section:
NCT03776695