Eligibility Details:
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
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
