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

August 30, 2026 updated by: Guoping Yang, The Third Xiangya Hospital of Central South University

A Randomized, Open-Label, Crossover Phase 1 Clinical Trial to Evaluate the Relative Bioavailability and Food Effect of a New Formulation of HBW-3220 Capsules in Healthy Participants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 adult participants.

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 of the following treatments: the previous formulation of HBW-3220 capsules under fasting conditions, the new formulation under fasting conditions, or the new formulation after a high-fat, high-calorie meal. Each participant will receive all three treatments, with a washout period of at least 7 days between doses.

Blood samples for pharmacokinetic assessment will be collected before dosing and through 72 hours after each dose. The primary pharmacokinetic parameters include maximum plasma concentration (Cmax), area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t), and area under the curve extrapolated to infinity (AUC0-inf). Relative bioavailability will be assessed by comparing the new and previous formulations under fasting conditions. The effect of food will be assessed by comparing the new formulation under fed and fasting conditions.

Safety and tolerability will be evaluated using adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms. A safety follow-up will be conducted 10 ± 2 days after the last dose.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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.
  2. Aged 18 to 55 years, inclusive.
  3. 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.
  4. Able to tolerate a high-fat meal.
  5. 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.

Exclusion Criteria:

  1. 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.
  2. History of allergy to drugs, food, or other substances, or known hypersensitivity to any component or excipient of HBW-3220 capsules.
  3. Unable to tolerate venipuncture, difficult venous access, or a history of fainting during needle insertion or blood collection.
  4. Surgery within 3 months before the study or planned surgery during the study.
  5. Use of any medication or health supplement, including Chinese herbal medicines, within 14 days before the study.
  6. 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.
  7. Participation in another clinical trial involving administration of an investigational drug within 3 months before the study.
  8. 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.
  9. Pregnant or breastfeeding women, or participants unable or unwilling to use one or more non-pharmacological contraceptive measures during the study.
  10. Special dietary requirements, inability to comply with the standardized diet, or difficulty swallowing.
  11. Consumption of more than 8 cups of tea, coffee, and/or caffeine-containing beverages per day, with 1 cup defined as 250 mL.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. Positive test for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody.
  17. Presence or history of cardiac disease, including but not limited to congenital long QT syndrome, torsades de pointes, or risk factors for torsades de pointes, such as cardiac insufficiency, hypokalemia, or a family history of long QT syndrome; current use of Class IA antiarrhythmic drugs, such as quinidine or procainamide, Class III antiarrhythmic drugs, such as amiodarone or sotalol, or other drugs known to affect the QT interval; or a screening Fridericia-corrected QT interval (QTcF) of at least 450 ms for males or at least 460 ms for females, PR interval greater than 200 ms, or QRS interval of at least 120 ms.
  18. Receipt of any live vaccine within 30 days before the first dose.
  19. Consumption of grapefruit-containing products or other beverages or foods that may affect drug absorption, distribution, metabolism, or excretion within 48 hours before the first dose.
  20. Any other condition that, in the investigator's opinion, may prevent the participant from completing the study or make the participant unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence A: Old Fasted - New Fasted - New Fed
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
A single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions.
Drug: HBW-3220 New Formulation Under Fasting Conditions
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions.
Drug: HBW-3220 New Formulation Under Fed Conditions
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.
Experimental: Sequence B: New Fasted - New Fed - Old Fasted
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
A single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions.
Drug: HBW-3220 New Formulation Under Fasting Conditions
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions.
Drug: HBW-3220 New Formulation Under Fed Conditions
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.
Experimental: Sequence C: New Fed - Old Fasted - New Fasted
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
A single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions.
Drug: HBW-3220 New Formulation Under Fasting Conditions
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions.
Drug: HBW-3220 New Formulation Under Fed Conditions
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of HBW-3220
Time Frame: 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
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
Time Frame: Predose through 72 hours after dosing in each of the three treatment periods
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
Time Frame: Predose through 72 hours after dosing in each of the three treatment periods
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Third Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HBW-3220-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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