inclusion criteria: subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form; subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned; male or female, aged 18 to 55 years (inclusive) at the time of signing the informed consent form (icf); subject must be willing to undergo covid-19 testing per clinical pharmacology unit /phase 1 clinic guidelines; subject must complete full covid-19 vaccination course at least 2 weeks prior to study drug administration; minimum body weight of ≥50 kg (110 lbs) for men and ≥45 kg (99 lbs) for women. maximum body weight of ≤100 kg (220 lbs). body mass index from 18 to 30 kg/m2 (values rounded to the nearest 10th of a unit); healthy as determined by a responsible and experienced physician, based on a medical evaluation, including medical history, physical examination, laboratory tests, and ecg: no evidence of clinically significant cardiac, pulmonary, hepatic, biliary, gastrointestinal, or renal disorders, or cancer within the past 5 years (except localized or in situ cancer of the skin); aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase, bilirubin, and creatinine lower than or equal to the uln. abnormal values can be repeated once at the discretion of the investigator or designee; white blood cell count (including differential), hemoglobin and platelets must be above the lower limit of normal, and if above the uln, must not be clinically significant in the opinion of the investigator. a subject with laboratory values outside the reference range may be included at the investigator's discretion if it is considered clinically insignificant, unlikely to introduce additional risk factors and, in their opinion, does not interfere with study procedures; women of childbearing potential (wocbp*) must use a highly effective form of birth control (confirmed by the investigator). rhythm methods will not be considered as a highly effective method of birth control. highly effective forms of birth control include: abstinence; vasectomized partner (provided that the partner is the sole sexual partner of wocbp and that the vasectomized partner has received medical assessment of the surgical success); oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormone contraception associated with inhibition of ovulation; any effective intrauterine device/levonorgestrel intrauterine system; female sterilization by tubal occlusion; wocbp must agree to use a highly effective method of birth control, as defined above, from the time of signing the icf, throughout the study duration and until 30 days after the last dose of study drug. volunteers must have a negative serum pregnancy test result at screening; *wocbp are defined as women who are not permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), and who are not post-menopausal. women will be considered post-menopausal if they have been amenorrhoeic for at least 12 months without an alternative medical cause and follicle stimulating hormone (fsh) > 40 iu/ml. non-vasectomized male volunteers must use an adequate method of contraception (condom with spermicide) from signing the icf throughout the study duration and until 30 days after the last dose of study drug. male volunteers must not donate sperm from time of signing the icf until at least 30 days after the last dose of the study drug.

inclusion criteria: subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form; subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned; male or female, aged 18 to 55 years (inclusive) at the time of signing the informed consent form (icf); subject must be willing to undergo covid-19 testing per clinical pharmacology unit /phase 1 clinic guidelines; subject must complete full covid-19 vaccination course at least 2 weeks prior to study drug administration; minimum body weight of ≥50 kg (110 lbs) for men and ≥45 kg (99 lbs) for women. maximum body weight of ≤100 kg (220 lbs). body mass index from 18 to 30 kg/m2 (values rounded to the nearest 10th of a unit); healthy as determined by a responsible and experienced physician, based on a medical evaluation, including medical history, physical examination, laboratory tests, and ecg: no evidence of clinically significant cardiac, pulmonary, hepatic, biliary, gastrointestinal, or renal disorders, or cancer within the past 5 years (except localized or in situ cancer of the skin); aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase, bilirubin, and creatinine lower than or equal to the uln. abnormal values can be repeated once at the discretion of the investigator or designee; white blood cell count (including differential), hemoglobin and platelets must be above the lower limit of normal, and if above the uln, must not be clinically significant in the opinion of the investigator. a subject with laboratory values outside the reference range may be included at the investigator's discretion if it is considered clinically insignificant, unlikely to introduce additional risk factors and, in their opinion, does not interfere with study procedures; women of childbearing potential (wocbp*) must use a highly effective form of birth control (confirmed by the investigator). rhythm methods will not be considered as a highly effective method of birth control. highly effective forms of birth control include: abstinence; vasectomized partner (provided that the partner is the sole sexual partner of wocbp and that the vasectomized partner has received medical assessment of the surgical success); oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormone contraception associated with inhibition of ovulation; any effective intrauterine device/levonorgestrel intrauterine system; female sterilization by tubal occlusion; wocbp must agree to use a highly effective method of birth control, as defined above, from the time of signing the icf, throughout the study duration and until 30 days after the last dose of study drug. volunteers must have a negative serum pregnancy test result at screening; *wocbp are defined as women who are not permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), and who are not post-menopausal. women will be considered post-menopausal if they have been amenorrhoeic for at least 12 months without an alternative medical cause and follicle stimulating hormone (fsh) > 40 iu/ml. non-vasectomized male volunteers must use an adequate method of contraception (condom with spermicide) from signing the icf throughout the study duration and until 30 days after the last dose of study drug. male volunteers must not donate sperm from time of signing the icf until at least 30 days after the last dose of the study drug.