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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT05627258
Eligibility Criteria:
* INCLUSION CRITERIA:
A subject must meet all of the following criteria:
1. Willing and able to complete the informed consent process.
2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
3. Available for clinical follow-up through the last study visit.
4. 18 to 60 years of age.
5. In good general health without clinically significant medical history.
6. Physical examination without clinically significant findings within the 56 days prior to enrollment.
7. Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to SC group.
8. Willing to have blood samples collected, stored indefinitely, and used for research purposes.
Laboratory Criteria within 56 days prior to enrollment:
9. White blood cell count (WBC): 2,500-12,000/mm3.
10. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
11. Platelets: 125,000 - 500,000/mm3.
12. Hemoglobin within institutional normal range or accompanied by PI or designee approval.
13. Creatinine: \<= 1.1 x Upper Limit of Normal (ULN).
14. ALT: \<= 1.25 x ULN.
15. AST: \<= 1.25 x ULN.
16. Negative for HIV infection by an FDA approved method of detection.
Female-Specific Criteria:
17. Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.
18. Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
EXCLUSION CRITERIA:
A subject will be excluded if one or more of the following conditions apply:
1. Woman who is breast-feeding or planning to become pregnant during study participation.
2. Weight \> 115 kg.
3. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.
4. Hypertension that is not well controlled.
5. Receipt of any investigational study product within 28 days prior to enrollment (Note: Emergency Use Authorization of a COVID-19 vaccine is not exclusionary).
6. Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.
7. Receipt of any live attenuated vaccine within 28 days prior to enrollment.
8. Receipt of any vaccine within 2 weeks prior to enrollment.
9. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
10. Any other chronic or clinically significant medical condition that in the opinion of the 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, infectious disease, autoimmune disease, psychiatric disorder, heart disease, or cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05627258
Study Brief:
Protocol Section:
NCT05627258