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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT04230057
Eligibility Criteria:
Inclusion Criteria:
* A potential subject must meet all the following inclusion criteria to be eligible to participate in the study.
1. Health questionnaire filled on the day of recruitment, after signing the written consent form
2. Participants must receive administration of study agent within 21-28 calendar days of being selected as subject after screening procedure is completed
3. Healthy male or female subjects aged ≥18 and ≤40 years of age
4. Subjects must have a body mass index (BMI) between 18.0-29.9 kg/m² inclusive
5. CBC/differential obtained within 14 calendar days prior to selection as subject for drug administration , with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb
≥ 8.0 g/dl is acceptable.);
6. Adequate renal and hepatic function within 14 calendar days prior to selection as subject for drug administration defined as follows: Serum creatinine \< 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to selection as subject for drug administration, determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)
7. Total bilirubin \< 2 x the institutional Upper limit of Normal range (ULN) within 14 calendar days prior to selection as subject for drug administration
8. AST or ALT ≤ 3 x the institutional ULN within 14 calendar days prior to selection as subject for drug administration
9. ALP or GGT ≤ 2.5 x the institutional ULN within 14 calendar days prior to selection as subject for drug administration
10. Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to selection as subject for drug administration, with the following required parameters: Magnesium: \> 0.9 mg/dl or \< 3 mg/dl; Calcium: \> 7 mg/dl or \< 12.5 mg/dl; Glucose: \> 40 mg/dl or \< 250 mg/dl; Potassium: \> 3 mmol/L or \< 6 mmol/L; Sodium: \> 130 mmol/L or \< 155 mmol/L.
11. Participant must have active health insurance coverage at the time of study
12. Participants must be able to understand study-specific information and instructions in English.
13. Participant must be willing to fully comply with study procedures and restrictions.
14. Participant must be able to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any studyrelated procedures
Exclusion Criteria:
1. History of active liver disease or cancer.
2. Severe current or recurrent comorbidity such as (e.g., cardiovascular, haematological, neurological, endocrine, renal, liver, GI, HIV-AIDS, or other conditions such as cancer) that could affect the absorption and/or disposition of ATB
3. Any disease/illness diagnosed by a licensed physician.
4. Blood report positive for HIV and/or Hepatitis B and C tests
5. Has had an acute illness within two weeks prior to screening.
6. Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
7. Concurrent use of any prescription medication (including medicinal botanical) except birth control pills, over the counter medication and supplements except Vitamins and mineral supplements, or herbal supplements in form of herbal mixtures, teas or individual compounds (such as querctein, curcumin, echinacea, flaxseed, ginseng, ginkgo, soy etc.) that the study PI believes could potentially impact the results/objectives of this study.
8. Concurrent use of recreational drugs or alcohol during the study (self-declared by study participants)
9. Prisoners
10. Economically and/or educationally disadvantaged persons
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04230057
Study Brief:
Protocol Section:
NCT04230057