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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT01993706
Eligibility Criteria:
* INCLUSION CRITERIA:
A volunteer must meet all of the following criteria:
1. Able and willing to complete the informed consent process.
2. 18 to 50 years of age.
3. Based on history and examination, must be in general good health without history of any of the conditions listed in the exclusion criteria.
4. Willing to have blood samples collected, stored indefinitely, and used for research purposes. \[Note: Donation of mucosal samples is encouraged but not mandatory for eligibility.\]
5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
6. Screening laboratory values within 84 days prior to enrollment must meet the following criteria:
* WBC 2,500-12,000/mm3
* WBC differential either within institutional normal range or accompanied by the Principal Investigator or designee approval.
* Platelets equal to 125,000 400,000/mm3
* Hemoglobin within institutional normal range or accompanied by the Principal Investigator or designee approval.
* Creatinine less than or equal to 1.1 x ULN
* ALT less than or equal to 1.25 x ULN
* Negative HIV serology
FEMALE SPECIFIC CRITERIA:
7. If a woman is sexually active with a male partner and has no history of hysterectomy, tubal ligation or menopause, she must agree to use a prescription birth control method or a barrier birth control method from the time of study enrollment until the last study visit, or have a monogamous partner who has previously undergone a vasectomy.
8. Negative \<=-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following conditions apply:
1. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
2. Weight \>115 kg or \<53 kg.
3. History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence.
4. Hypertension that is not well controlled.
5. Woman who is breast-feeding, or planning to become pregnant during the 16 weeks of study participation.
6. Receipt of any investigational study agent within 28 days prior to enrollment or any past receipt of an investigational HIV vaccine.
7. Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. Including, but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01993706
Study Brief:
Protocol Section:
NCT01993706