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

NCT07799597 | Not Yet Recruiting Phase 1

• 1 other identifier: HBW-3220-103
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

HBW-3220; Relative Bioavailability; Food Effect; Pharmacokinetics; Formulation Comparison; Bruton Tyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (3)

• 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.

  Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, and 72 hours after dosing in each of the three treatment periods

• 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.

  Predose through 72 hours after dosing in each of the three treatment periods

• 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.

  Predose through 72 hours after dosing in each of the three treatment periods

Study Arms (3)

Sequence A: Old Fasted - New Fasted - New Fed

EXPERIMENTAL

Participants receive a single oral dose of HBW-3220 120 mg (four 30 mg capsules) in each of three treatment periods. In Period 1, participants receive the old formulation under fasting conditions. In Period 2, participants receive the new formulation under fasting conditions. In Period 3, participants receive the new formulation after a high-fat, high-calorie meal. The washout period between doses is at least 7 days.

Drug: HBW-3220 Old Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fed Conditions

Sequence B: New Fasted - New Fed - Old Fasted

EXPERIMENTAL

Participants receive a single oral dose of HBW-3220 120 mg (four 30 mg capsules) in each of three treatment periods. In Period 1, participants receive the new formulation under fasting conditions. In Period 2, participants receive the new formulation after a high-fat, high-calorie meal. In Period 3, participants receive the old formulation under fasting conditions. The washout period between doses is at least 7 days.

Drug: HBW-3220 Old Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fed Conditions

Sequence C: New Fed - Old Fasted - New Fasted

EXPERIMENTAL

Participants receive a single oral dose of HBW-3220 120 mg (four 30 mg capsules) in each of three treatment periods. In Period 1, participants receive the new formulation after a high-fat, high-calorie meal. In Period 2, participants receive the old formulation under fasting conditions. In Period 3, participants receive the new formulation under fasting conditions. The washout period between doses is at least 7 days.

Drug: HBW-3220 Old Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fed Conditions

Interventions

HBW-3220 New Formulation Under Fed Conditions DRUG

A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.

Sequence A: Old Fasted - New Fasted - New Fed; Sequence B: New Fasted - New Fed - Old Fasted; Sequence C: New Fed - Old Fasted - New Fasted

HBW-3220 Old Formulation Under Fasting Conditions DRUG

A single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions.

Sequence A: Old Fasted - New Fasted - New Fed; Sequence B: New Fasted - New Fed - Old Fasted; Sequence C: New Fed - Old Fasted - New Fasted

HBW-3220 New Formulation Under Fasting Conditions DRUG

A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions.

Sequence A: Old Fasted - New Fasted - New Fed; Sequence B: New Fasted - New Fed - Old Fasted; Sequence C: New Fed - Old Fasted - New Fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• No unprotected sexual intercourse within 2 weeks before screening. Participants must have no plans for conception and must agree to use effective contraceptive measures from screening until 3 months after the last dose of the study drug.

You may not qualify if:

• 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.
• Use of any medication or health supplement, including Chinese herbal medicines, within 14 days before the study.
• Use of any medication that inhibits or induces hepatic drug metabolism within 30 days before the study, including but not limited to inducers such as barbiturates, carbamazepine, phenytoin, glucocorticoids, and omeprazole, or inhibitors such as selective serotonin reuptake inhibitors, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and antihistamines.
• Participation in another clinical trial involving administration of an investigational drug within 3 months before the study.
• Blood donation or significant blood loss of 200 mL or more, excluding menstrual blood loss, blood transfusion, or use of blood products within 3 months before enrollment.
• Pregnant or breastfeeding women, or participants unable or unwilling to use one or more non-pharmacological contraceptive measures during the study.
• Special dietary requirements, inability to comply with the standardized diet, or difficulty swallowing.
• Consumption of more than 8 cups of tea, coffee, and/or caffeine-containing beverages per day, with 1 cup defined as 250 mL.
• Positive nicotine test before the first dose, smoking more than 5 cigarettes per day within 3 months before the study, or inability to abstain from all tobacco products during the study.
• Positive alcohol test before the first dose; regular alcohol consumption within 6 months before the study, defined as more than 14 units of alcohol per week, where 1 unit equals 360 mL of beer, 45 mL of spirits containing 40% alcohol, or 150 mL of wine; or inability to abstain from alcohol-containing products during the study.
• Positive drug abuse screening before the first dose; use of soft drugs, such as marijuana, within 3 months before the study; or use of hard drugs, such as cocaine or phencyclidine, within 1 year before the study.
• Abnormal vital signs, defined as systolic blood pressure below 90 mmHg or at least 140 mmHg, diastolic blood pressure below 60 mmHg or at least 90 mmHg, heart rate below 50 bpm or above 100 bpm; or clinically significant abnormalities in physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, or laboratory examinations, as determined by the investigator.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 2, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08