A 3-Part Study to Evaluate the Safety, Tolerability, PK, and Food Effect of BMB-101 in Healthy Volunteers

This study is designed as a 3-part study:

Part 1 is designed as single ascending dose (SAD) escalation study investigating 4 dose levels. Each cohort will consist of participants to be randomly assigned to receive a blinded oral dose of BMB-101 or placebo.

Part 2 is designed as a randomized, orally administered, single-dose, two-treatment (fed vs fasted), two-period, two-sequence crossover to assess the effects of a standard high-fat breakfast on PK of BMB-101.

Part 3 is designed as a multiple ascending dose (MAD) escalation study investigating up to 4 dose levels. Subjects will be randomized to receive double-blind treatment of BMB-101 or matching placebo twice daily for 7 days.

Key Inclusion Criteria:

• Subject must be aged between 18 and 55 years (both inclusive).
• Healthy subjects with no clinically significant screening results.
• Body mass index (BMI) 18.0 to 32.0 kg/m².
• Males and non pregnant females willing to use contraceptives consistent with local regulations from screening through 3 months after the last dose of study medication.
• Agree to frequent blood and urine sampling during the course of the study.
• Agree to be confined in the study unit and follow study procedures.

Key Exclusion Criteria:

• Subjects with unstable or severe illness as indicated on medical history, physical examination, or clinical laboratory, vital signs, and electrocardiograms (ECGs) evaluations, or in the opinion of the Investigator.
• Subjects with reported history within past 6 months of, or current treatment for, any GI disease that may impact the absorption of an oral drug for example gastroesophageal reflux disorder, peptic ulcer disease, inflammatory bowel disease.
• Subjects with a history of seizures other than febrile seizures as a child.
• Subjects with history of or current glucose intolerance; or with history of gestational diabetes.
• Subjects with lifetime history of suicidal behavior or with lifetime history of suicidal ideation as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Subjects with any use of or intent to use any medications, including prescription, over-the-counter (OTC), herbal preparations, or vitamin/mineral supplementation, other than study medications, from 7 days prior to first dose through follow-up visit.
• Female subjects with a positive pregnancy test at Screening or Day -1 or who are breastfeeding.
• Subjects who have used more than 5 cigarettes, cigars, or nicotine-containing products per month within 6 months prior to first study dose, or plan to use them through completion of the follow-up visit.
• Subjects with a positive drug screen for illegal drugs including cannabis at Screening or Day -1.