Healthy SubjectsPhase 1NCT06306872
A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules
A Phase 1 study testing Sequence A ABSK-011 and Sequence B ABSK-011 in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Sequence A ABSK-011 and Sequence B ABSK-011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2024to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged between 18 and 45 years (including 18 and 45 years) at the time of screening;
- Male ≥50 kg, female ≥45kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI= weight (kg)/height (m) 2;
- Physical examination, laboratory examination and other relevant examination results before the first medication are normal or abnormal but meet the following requirements, or other abnormal results but not clinically significant determined by the investigator:
- 35.9℃≤ ear temperature ≤37.5℃;
- pulse rate ≥55 times/min and ≤100 times/min;
- Systolic blood pressure ≥90 mmHg and < 140 mmHg, diastolic blood pressure ≥60mmHg and < 90 mmHg;
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- Total bilirubin (TBIL) ≤1.5×ULN;
- Fertile male or female subjects must consent to the use of an effective contraceptive method during the study period and for 6 months after the last dose of the investigational drug is administered (And male subjects do not donate sperm during this period, and female subjects do not donate eggs during this period; Female subjects must be non-pregnant and non-lactating female subjects, defined as women in a state of pregnancy from conception to termination of pregnancy, as determined by laboratory human chorionic gonadotropin (hCG) test within 7 days before the start of the study;
- Voluntarily participate in this clinical trial, understand the study procedure and sign the informed consent before screening; Good compliance, willing to follow study procedures.
Who cannot join
- Patients with medical history or existing diseases of motor system, neuropsychiatric system, endocrine system, blood circulatory system, respiratory system, digestive system, urinary system, reproductive system, and other abnormalities, and those determined by the investigator to be clinically significant ;
- A known or persistent mental disorder that may interfere with the participant's participation in the study, as determined by the investigator;
- Known allergic history to food, environment, experimental drug ABSK-011 or other drugs;
- Participants who have participated in other clinical trials and used other clinical trial drugs or test devices within 3 months before or during the screening period, or plan to participate in other clinical trials during the study period, or participants who do not participate in clinical trials themselves;\
- have previously participated in this study or any other study related to ABSK-011 as a subject and have taken ABSK-011;
- Patients who had used proton pump inhibitors (including omeprazole, Lansoprazole, Rabeprazole, pantoprazole, etc.) within 14 days before the first dose;
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- Those who have used strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, pomegranates, star fruits, grapefruits, Seville oranges and fruit juices or other processed products) within 14 days before the first dose, or have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products;
- For those who have used CYP2C19 inhibitors or inducers (including fluoxetine, fluvoxamine, ticlopidine, rifamepine) within 14 days before the first dose, (Part C only);
- There are factors that significantly affect drug absorption, distribution, metabolism and excretion, such as inability to take oral experimental drugs (dysphagia), significant nausea, vomiting and malabsorption, history of gastric or intestinal surgery, or other surgical history that affects drug absorption, distribution, metabolism and excretion (except appendicitis surgery);
- Patients with needle fainting, blood fainting history, or inability to tolerate venipunction, or difficulty in blood collection;
- Blood donation or heavy blood loss (≥400ml) within 3 months before or during screening (except female menstrual period);
- Have special dietary requirements, can not comply with the unified diet (such as the standard meal food intolerance, lactose intolerance, etc.) and the corresponding regulations, or have swallowing difficulties;
- Those who do not wish to comply with the dietary requirements/restrictions during the study period, which are: (i) only dietary supplements provided by the study center during hospitalization, (ii) avoiding CYP3A4 strong inhibitor or inducer during the study, and (iii) avoiding other CYP2C19 strong inhibitor or inducer during the study ( (iii) Only Part C);
- Those who consumed more than 14 units of alcohol per week in the 3 months prior to screening (1 unit of alcohol is about 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or whose alcohol breath test results were > 0mg/100ml, or those who cannot abstain from alcohol during the study;
- Smokers who smoked more than 5 cigarettes per day (or a corresponding amount of tobacco or nicotine products) in the 3 months prior to screening; Or unable to stop using any tobacco products during the trial;
- People who had excessive methylxanthine/caffeine consumption in the past 6 months (excess consumption was defined as consuming more than 6 units of caffeine per day, with 1 unit of caffeine equivalent to 177 ml of coffee, 355 ml of tea, 355 ml of cola, or 85 grams of chocolate), Or were unwilling to comply with the methylxanthine/caffeine use restrictions in 5.3.3 during the study period, or had a known history of substance abuse or screened positive for substance abuse;
- Hepatitis B surface antigen, treponema pallidum antibody, antibody to human immunodeficiency virus, antibody to hepatitis C antibody were abnormal and were clinically significant determined by the investigator;
- Patients with a history of bacterial, fungal, parasitic, viral (excluding nasopharyngitis) or mycobacterium infection within 45 days prior to the first administration, or imaging findings (chest radiograph) supporting related infections (as determined by the investigator);
- had been vaccinated within 2 months prior to the first dose, or intended to be vaccinated throughout the study period;
- Any other factors that the investigator considers inappropriate for participation in this trial, which may affect the participant's adherence to the protocol, interfere with the interpretation of the study results, or expose the participant to risk. Or subjects withdraw from the experiment for their own reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABSK061 Minitablets Following Single and Multiple Oral Doses and to Assess the Effect of Administration With Soft Foods in Healthy Adults
The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose
Read the detailed description
This study consists of three separate parts: Part A, Part B and Part C. Part A is designed as a two-period, open-label, two-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose.
Part B is designed as a three-period, open-label, three-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new ABSK-011 formulation versus the old formulation at high and low doses for single oral administration.
Part C was designed as a four-period, open-label, fixed-sequence study, the main objective of which was to evaluate the effects of low-fat diet, high-fat diet and omeprazole magnesium enteric-coated tablets on PK of the new ABSK-011 formulation after a single oral administration.
- Conditions
- Healthy Subjects
- Being tested
- Sequence A ABSK-011, Sequence B ABSK-011
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence A ABSK-011Drug
Subjects in sequence A will receive 220 mg (100 mg capsule *2 and 20 mg capsule *1) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 200 mg(100 mg capsule *2) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1).
Sequence B ABSK-011Drug
Subjects in sequence A will receive 200 mg(100 mg capsule *2) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 220 mg (100 mg capsule *2 and 20 mg capsule *1) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1).
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | Subjects in sequence A will be given ABSK-011 old formulation 220 mg (100 mg capsule *2 and 20 mg capsule *1) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and ABSK-011 new formulation 200 mg (100 mg capsule *2) on an empty stomach in the morning of the first day of cycle 2 (C2D1). Receives: Drug: Sequence A ABSK-011 |
| Sequence B | Other | Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule *2) on an empty stomach in the morning of Cycle 1 day (C1D1) and ABSK-011 old formulation 220 mg (100 mg capsule *2 and 20 mg capsule *1) on an empty stomach in the morning of the first day of cycle 2 (C2D1). Receives: Drug: Sequence B ABSK-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed concentration
Measured: From pre-dose up to 72 hours post-dose. assessed up to 12 months
AUC
Area under the concentration-time curve
Measured: From pre-dose up to 72 hours post-dose. assessed up to 12 months
tmax
Time to maximum observed concentration
Measured: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Secondary outcomes (5)
AEs
Adverse events
Measured: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 12 months.
SAEs SAEs
Serious adverse events (SAEs)
Measured: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 12 months.
t1/2
Elimination half-life
Measured: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Vz/F
Apparent volume of distribution
Measured: From pre-dose up to 72 hours post-dose. assessed up to 12 months
CL/F CL/F
Apparent oral clearance
Measured: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Feb 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe 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
- Model description
- Participants will be randomly assigned 1:1 to arms A (Sequence A) or arms B (Sequence B) to receive a single dose of ABSK-011 orally in two separate doses, spaced at least 4 days apart. Among them, subjects in sequence A will be given ABSK-011 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) and ABSK-011 200 mg (100 mg capsule \*2) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and the first day of cycle 2 (C2D1), respectively. Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule \*2) and ABSK-011 old formulation 220 mg (100 mg capsule \*2 and 20 mg capsule \*1) on an empty stomach in the morning of Cycle 1 day (C1D1) and cycle 2 day (C2D1), respectively.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306872
- Sponsor's protocol ID
- ABSK-011-102
- Status last verified
- Dec 2025
- First submitted
- 6 Feb 2024
- Last updated
- 10 Dec 2025
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABSK061 Minitablets Following Single and Multiple Oral Doses and to Assess the Effect of Administration With Soft Foods in Healthy Adults
- ClinicalTrials.gov ID
- NCT06306872
- Acronym / sponsor ID
- ABSK-011-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 12 Mar 2024 (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.
The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose
Detailed description
This study consists of three separate parts: Part A, Part B and Part C. Part A is designed as a two-period, open-label, two-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose.
Part B is designed as a three-period, open-label, three-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new ABSK-011 formulation versus the old formulation at high and low doses for single oral administration.
Part C was designed as a four-period, open-label, fixed-sequence study, the main objective of which was to evaluate the effects of low-fat diet, high-fat diet and omeprazole magnesium enteric-coated tablets on PK of the new ABSK-011 formulation after a single oral administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned 1:1 to arms A (Sequence A) or arms B (Sequence B) to receive a single dose of ABSK-011 orally in two separate doses, spaced at least 4 days apart. Among them, subjects in sequence A will be given ABSK-011 220 mg (100 mg capsule *2 and 20 mg capsule *1) and ABSK-011 200 mg (100 mg capsule *2) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and the first day of cycle 2 (C2D1), respectively. Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule *2) and ABSK-011 old formulation 220 mg (100 mg capsule *2 and 20 mg capsule *1) on an empty stomach in the morning of Cycle 1 day (C1D1) and cycle 2 day (C2D1), respectively.
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Drug: Sequence A ABSK-011Subjects in sequence A will be given ABSK-011 old formulation 220 mg (100 mg capsule *2 and 20 mg capsule *1) on an empty stomach in the morning of the first day of cycle 1 (C1D1) and ABSK-011 new formulation 200 mg (100 mg capsule *2) on an empty stomach in the morning of the first day of cycle 2 (C2D1). |
| Sequence B | Other | Drug: Sequence B ABSK-011Subjects in sequence B will be given ABSK-011 new formulation 200 mg (100 mg capsule *2) on an empty stomach in the morning of Cycle 1 day (C1D1) and ABSK-011 old formulation 220 mg (100 mg capsule *2 and 20 mg capsule *1) on an empty stomach in the morning of the first day of cycle 2 (C2D1). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy subjects aged between 18 and 45 years (including 18 and 45 years) at the time of screening;
- Male ≥50 kg, female ≥45kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI= weight (kg)/height (m) 2;
- Physical examination, laboratory examination and other relevant examination results before the first medication are normal or abnormal but meet the following requirements, or other abnormal results but not clinically significant determined by the investigator:
- Fertile male or female subjects must consent to the use of an effective contraceptive method during the study period and for 6 months after the last dose of the investigational drug is administered (And male subjects do not donate sperm during this period, and female subjects do not donate eggs during this period; Female subjects must be non-pregnant and non-lactating female subjects, defined as women in a state of pregnancy from conception to termination of pregnancy, as determined by laboratory human chorionic gonadotropin (hCG) test within 7 days before the start of the study;
- Voluntarily participate in this clinical trial, understand the study procedure and sign the informed consent before screening; Good compliance, willing to follow study procedures.
Key exclusion criteria (20 listed)
- Patients with medical history or existing diseases of motor system, neuropsychiatric system, endocrine system, blood circulatory system, respiratory system, digestive system, urinary system, reproductive system, and other abnormalities, and those determined by the investigator to be clinically significant ;
- A known or persistent mental disorder that may interfere with the participant's participation in the study, as determined by the investigator;
- Known allergic history to food, environment, experimental drug ABSK-011 or other drugs;
- Participants who have participated in other clinical trials and used other clinical trial drugs or test devices within 3 months before or during the screening period, or plan to participate in other clinical trials during the study period, or participants who do not participate in clinical trials themselves;\
- have previously participated in this study or any other study related to ABSK-011 as a subject and have taken ABSK-011;
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 |
|---|---|---|
| Sequence A ABSK-011Subjects in sequence A will receive 220 mg (100 mg capsule *2 and 20 mg capsule *1) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 200 mg(100 mg capsule *2) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1). | Drug | Sequence A |
| Sequence B ABSK-011Subjects in sequence A will receive 200 mg(100 mg capsule *2) Oral administration of ABSK-011 old formulation at the first day of cycle 1 (C1D1), followed by a washout period of at least 4 days.Subjects will receive 220 mg (100 mg capsule *2 and 20 mg capsule *1) Oral administration of ABSK-011 new formulation at the first day of cycle 2 (C2D1). | Drug | Sequence B |
Primary outcome
Cmax
Time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Maximum observed concentration
AUC
Time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Area under the concentration-time curve
tmax
Time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Time to maximum observed concentration
5 secondary outcomes
AEs
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 12 months.
SAEs SAEs
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 12 months.
t1/2
Time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Vz/F
Time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months
CL/F CL/F
Time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sequence A ABSK-011 and Sequence B ABSK-011 in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
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 9 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (time frame: From pre-dose up to 72 hours post-dose. assessed up to 12 months). 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 10 Dec 2025.