• Aged ≥ 18 years at the time of informed consent.

• At the discretion of the PI or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP.

• Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 kg.

• Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.

• Not pregnant or breastfeeding, or willing to cease breastfeeding.

• Woman of childbearing potential or fertile man agrees to use an acceptable method of contraception from the start of Screening until 90 days after the last dose of IP. Acceptable methods of contraception are defined in protocol.

• Notes:

⁃ Males must be surgically sterile (\> 30 days since vasectomy with no viable sperm) or, if engaged in sexual relations with a WOCBP, must agree to use an acceptable contraceptive method.

⁃ Females or males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle.

⁃ Males must not donate sperm from the first dose of IP until at least 90 days after the last dose of IP.

• Able and willing to attend the necessary visits to the study site.

• Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.