Healthy VolunteersPhase 1NCT07799597
Comparison of HBW-3220 Capsule Formulations and the Effect of Food in Healthy Participants
A Phase 1 study testing HBW-3220 Old Formulation Under Fasting Conditions, HBW-3220 New Formulation Under Fasting Conditions and HBW-3220 New Formulation Under Fed Conditions in people with Healthy Volunteers, run by The Third Xiangya Hospital of Central South University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HBW-3220 Old Formulation Under Fasting Conditions, HBW-3220 New Formulation Under Fasting Conditions and HBW-3220 New Formulation Under Fed Conditions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Positive test for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody.
- 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.
- Receipt of any live vaccine within 30 days before the first dose.
- 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.
- Any other condition that, in the investigator's opinion, may prevent the participant from completing the study or make the participant unsuitable for enrollment.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- HBW-3220 Old Formulation Under Fasting Conditions, HBW-3220 New Formulation Under Fasting Conditions, HBW-3220 New Formulation Under Fed Conditions
- Keywords
- HBW-3220, Relative Bioavailability, Food Effect, Pharmacokinetics, Formulation Comparison, Bruton Tyrosine Kinase Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBW-3220 Old Formulation Under Fasting ConditionsDrug
A 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 ConditionsDrug
A 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 ConditionsDrug
A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: HBW-3220 Old Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fasting Conditions; Drug: HBW-3220 New Formulation Under Fed Conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Predose through 72 hours after dosing in each of the three treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799597
- Sponsor's protocol ID
- HBW-3220-103
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07799597
- Acronym / sponsor ID
- HBW-3220-103
- Conditions
- Healthy Volunteers
- Keywords
- HBW-3220, Relative Bioavailability, Food Effect, Pharmacokinetics, Formulation Comparison, Bruton Tyrosine Kinase Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Old Fasted - New Fasted - New Fed | Experimental | Drug: HBW-3220 Old Formulation Under Fasting Conditions, Drug: HBW-3220 New Formulation Under Fasting Conditions, Drug: HBW-3220 New Formulation Under Fed ConditionsParticipants 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. |
| Sequence B: New Fasted - New Fed - Old Fasted | Experimental | Drug: HBW-3220 Old Formulation Under Fasting Conditions, Drug: HBW-3220 New Formulation Under Fasting Conditions, Drug: HBW-3220 New Formulation Under Fed ConditionsParticipants 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. |
| Sequence C: New Fed - Old Fasted - New Fasted | Experimental | Drug: HBW-3220 Old Formulation Under Fasting Conditions, Drug: HBW-3220 New Formulation Under Fasting Conditions, Drug: HBW-3220 New Formulation Under Fed ConditionsParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBW-3220 Old Formulation Under Fasting ConditionsA single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions. | Drug | 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 ConditionsA single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions. | Drug | 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 Fed ConditionsA single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal. | Drug | Sequence A: Old Fasted - New Fasted - New Fed, Sequence B: New Fasted - New Fed - Old Fasted, Sequence C: New Fed - Old Fasted - New Fasted |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBW-3220 Old Formulation Under Fasting Conditions, HBW-3220 New Formulation Under Fasting Conditions and HBW-3220 New Formulation Under Fed Conditions in people with Healthy Volunteers, run by The Third Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.