Comparison of HBW-3220 Capsule Formulations and the Effect of Food in Healthy Participants

HBW‐3220 is a reversible Bruton tyrosine kinase (BTK) inhibitor. This is a randomized,open‐label, three‐period, three‐sequence crossover Phase 1 study in 21 healthy adultparticipants.Participants will be randomized in a 1:1:1 ratio to one of three treatment sequences.During each study period, participants will receive a single 120 mg oral dose of one ofthe following treatments: the previous formulation of HBW‐3220 capsules under fastingconditions, the new formulation under fasting conditions, or the new formulation after ahigh‐fat, high‐calorie meal. Each participant will receive all three treatments, with awashout period of at least 7 days between doses.Blood samples for pharmacokinetic assessment will be collected before dosing and through72 hours after each dose. The primary pharmacokinetic parameters include maximum plasmaconcentration (Cmax), area under the plasma concentration‐time curve from time zero tothe last measurable concentration (AUC0‐t), and area under the curve extrapolated toinfinity (AUC0‐inf). Relative bioavailability will be assessed by comparing the new andprevious formulations under fasting conditions. The effect of food will be assessed bycomparing the new formulation under fed and fasting conditions.Safety and tolerability will be evaluated using adverse events, vital signs, physicalexaminations, clinical laboratory tests, and 12‐lead electrocardiograms. A safetyfollow‐up will be conducted 10 ± 2 days after the last dose.