This Phase 1 study will evaluate a new formulation of HBW-3220 capsules in healthy adults. It will compare how much and how quickly HBW-3220 enters the bloodstream after a single 120 mg dose of the new formulation versus the previous formulation under fasting conditions, and after the new formulation is taken under fed versus fasting conditions. Twenty-one participants will be randomly assigned to one of three treatment sequences and will receive all three treatments during three study periods, with at least 7 days between doses. Blood samples will be collected for pharmacokinetic analysis, and safety and tolerability will be assessed throughout the study and during follow-up.
The participant has provided written informed consent before any study-related activity, fully understands the purpose and significance of the study, and is willing to comply with the study protocol.
Aged 18 to 55 years, inclusive.
Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg. Body mass index (BMI) must be between 19.0 and 26.0 kg/m2, inclusive.
Able to tolerate a high-fat meal.
History or current presence of any clinically significant disease involving the circulatory, endocrine, nervous, digestive, respiratory, genitourinary, hematologic, immune, psychiatric, or metabolic systems, or any other disease that may interfere with the study results, including but not limited to deep vein thrombosis, pulmonary embolism, bleeding disorders, or poorly controlled infection.
History of allergy to drugs, food, or other substances, or known hypersensitivity to any component or excipient of HBW-3220 capsules.
Unable to tolerate venipuncture, difficult venous access, or a history of fainting during needle insertion or blood collection.
Surgery within 3 months before the study or planned surgery during the study.
Crossover
HBW-3220 Old Formulation Under Fasting Conditions
DrugA single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions.
HBW-3220 New Formulation Under Fasting Conditions
DrugA single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions.
HBW-3220 New Formulation Under Fed Conditions
DrugA single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.
Maximum Observed Plasma Concentration (Cmax) of HBW-3220
Maximum observed plasma concentration of HBW-3220 will be calculated from plasma concentration-time data using noncompartmental analysis. Cmax will be compared between the new and old formulations under fasting conditions and between the fed and fasting conditions for the new formulation.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of HBW-3220
AUC0-t of HBW-3220 will be calculated from plasma concentration-time data using noncompartmental analysis. AUC0-t will be compared between the new and old formulations under fasting conditions and between the fed and fasting conditions for the new formulation.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of HBW-3220
AUC0-inf of HBW-3220 will be calculated from plasma concentration-time data using noncompartmental analysis. AUC0-inf will be compared between the new and old formulations under fasting conditions and between the fed and fasting conditions for the new formulation.
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