Overview
This trial is a Phase 1a/1b, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of prosetin administered to healthy adult subjects.
Eligibility
Key Inclusion Criteria:
- Adults between 18 and 65 years of age, inclusive
- BMI within 18.0 to 32.0 kg/m2, inclusive
- In good health, in the opinion of the Investigator, as determined by a physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments
- Females of childbearing potential must agree to an approved method of contraception
Key Exclusion Criteria:
- History or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, neurological, or psychiatric disorder
- Any episodes of vertigo in the previous 12 months prior to screening or any medical history of seizures
- Active autoimmune conditions such as systemic lupus erythematosus
- A diagnosis of cancer or evidence of continued disease within five years before screening