phase 2 inclusion criteria: 1. informed consent understood and signed prior to screening procedures 2. healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing 3. subject willing to comply with and be available for all protocol procedures for the duration of the study 4. subject determined by medical history, physical examination, and clinical judgement of the principal investigator (pi) to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria 5. subject with bmi ≥18.5 and ≤ 35 kg/m2 6. females of childbearing potential must have a negative urine pregnancy test on day 1 prior to dosing note: a woman is considered of childbearing potential unless post-menopausal (\> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy. 7. females of childbearing potential and males must agree to use medically effective contraception (methods with a failure rate of \< 1% per year when used consistently and correctly) from screening until last dose. acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle. 8. subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing 9. clinical laboratory results within normal ranges or are no greater than grade 1 and deemed not clinically significant by medical monitor and pi. (any subjects with results that are grade 2 or above according to toxicity table (modified from fda guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trial) will be excluded) 10. subject willing to provide verifiable identification and has means to be contacted and to contact the principal investigator (pi) during the study. phase 2

phase 2 inclusion criteria: 1. informed consent understood and signed prior to screening procedures 2. healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing 3. subject willing to comply with and be available for all protocol procedures for the duration of the study 4. subject determined by medical history, physical examination, and clinical judgement of the principal investigator (pi) to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria 5. subject with bmi ≥18.5 and ≤ 35 kg/m2 6. females of childbearing potential must have a negative urine pregnancy test on day 1 prior to dosing note: a woman is considered of childbearing potential unless post-menopausal (\> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy. 7. females of childbearing potential and males must agree to use medically effective contraception (methods with a failure rate of \< 1% per year when used consistently and correctly) from screening until last dose. acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle. 8. subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing 9. clinical laboratory results within normal ranges or are no greater than grade 1 and deemed not clinically significant by medical monitor and pi. (any subjects with results that are grade 2 or above according to toxicity table (modified from fda guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trial) will be excluded) 10. subject willing to provide verifiable identification and has means to be contacted and to contact the principal investigator (pi) during the study. phase 2

phase 2 inclusion criteria: informed consent understood and signed prior to screening procedures healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing subject willing to comply with and be available for all protocol procedures for the duration of the study subject determined by medical history, physical examination, and clinical judgement of the principal investigator (pi) to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria subject with bmi ≥18.5 and ≤ 35 kg/m2 females of childbearing potential must have a negative urine pregnancy test on day 1 prior to dosing note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy. females of childbearing potential and males must agree to use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) from screening until last dose. acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle. subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing clinical laboratory results within normal ranges or are no greater than grade 1 and deemed not clinically significant by medical monitor and pi. (any subjects with results that are grade 2 or above according to toxicity table (modified from fda guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trial) will be excluded) subject willing to provide verifiable identification and has means to be contacted and to contact the principal investigator (pi) during the study. phase 2

phase 2 inclusion criteria: informed consent understood and signed prior to screening procedures healthy male or non-pregnant, non-lactating female 18 years of age or older, inclusive on the day of dosing subject willing to comply with and be available for all protocol procedures for the duration of the study subject determined by medical history, physical examination, and clinical judgement of the principal investigator (pi) to be eligible for inclusion in the study by meeting all the inclusion criteria and no exclusion criteria subject with bmi ≥18.5 and ≤ 35 kg/m2 females of childbearing potential must have a negative urine pregnancy test on day 1 prior to dosing note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy. females of childbearing potential and males must agree to use medically effective contraception (methods with a failure rate of < 1% per year when used consistently and correctly) from screening until last dose. acceptable methods include: hormonal contraception including implants, injections or oral; two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide); intrauterine device or intrauterine system; abstinence when this is the subject's preferred and usual lifestyle. subject agrees to not donate bone marrow, blood, and blood products for at least 3 months after dosing clinical laboratory results within normal ranges or are no greater than grade 1 and deemed not clinically significant by medical monitor and pi. (any subjects with results that are grade 2 or above according to toxicity table (modified from fda guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trial) will be excluded) subject willing to provide verifiable identification and has means to be contacted and to contact the principal investigator (pi) during the study. phase 2