A First-in-Human Study of SBP-9330 in Healthy Subjects

Inclusion Criteria

• Provision of written informed consent prior to the initiation of any protocol-specific procedures
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Healthy male or female subject ≥ 18 and ≤ 55 years of age
• Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 32.0 kg/m2
• Body weight ≥ 50.0 kg at Screening
• A female subject must meet at least one of the following criteria: a. Is of childbearing potential and agrees to use an acceptable contraceptive method. b. Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e., at least 1 year without menses prior to the first study drug administration without an alternative medical condition and confirmed with a serum follicle-stimulating hormone [FSH] > 40 IU/L at Screening)
• Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from the first admission to the CRU until 90 days after the last study drug administration.
• Part A and B only: Never- or nonsmoker (a nonsmoker is defined as someone who completely stopped using nicotine products for at least 2 years prior to the first study drug administration)
• Have no clinically significant medical or mental health conditions captured in the medical history or evidence of clinically significant findings on the physical examination and/or ECG, as determined by an Investigator
• No clinically significant abnormalities in blood pressure, heart rate, body temperature and respiratory rate and no evidence of orthostatic hypotension or postural tachycardia at Screening.

Part C Only:

• Are current tobacco cigarette smokers who smoke an average of 10 or more cigarettes per day in the 30 days prior to Screening
• Expired breath CO level ≥10 parts per million (ppm) at Screening and prior to the first study drug administration
• Positive test result for cotinine at Screening and prior to the first study drug administration
• Are not motivated to try to quit smoking from Screening through 30 days from the first study drug administration

Exclusion Criteria

• Female who is lactating
• Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
• Female who is planning to become pregnant during this study or within 90 days after the last study drug administration
• Male with female partner who is pregnant, lactating, or planning to become pregnant during this study or within 90 days after the last study drug administration
• Poor venous access as determined by an Investigator at Screening
• History of significant hypersensitivity to SBP-9330 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Presence of any medical condition that, in the opinion of an Investigator, poses an unacceptable risk to the subjects
• Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug absorption
• Evidence or history of clinically significant cardiovascular, pulmonary, hematologic, psychiatric (including mood and substance use disorders), neurological (including migraines, seizures, and epilepsy), endocrine, renal, hepatic, gastrointestinal, immunologic or dermatologic disease
• History of malignancy within the past five years, except for successfully treated basal cell carcinoma of the skin
• History of suicidal ideation or suicidal behavior as per the C-SSRS questionnaire administered at Screening
• Evidence or history of significant psychiatric disease or any DSM-5 disorder as assessed by the Mini International Neuropsychiatric Interview (M.I.N.I.) administered at Screening
• Routine or chronic use of more than three grams of acetaminophen daily
• Strenuous activity, sunbathing, a