Solid TumorPhase 1NCT05391048
An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition
A Phase 1 study testing IMP4297(20mg) and IMP4297(10mg) in people with Solid Tumor, run by Impact Therapeutics, Inc. at 1 site in China.
Trial summary
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fed condition Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IMP4297(20mg) and IMP4297(10mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 21 Jul 2022
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for the study:
- The subject fully understands the objective, nature, method of the trial and possible adverse reactions, voluntarily acts as a subject, signs the informed consent form before any study procedure, and ensures that any procedure is performed by himself/herself.
- Healthy Chinese male subjects aged 18 to 55 years (inclusive) at Screening.
- Body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive); body weight ≥ 50.0 kg.
- Subject is able to communicate well with the Investigator and understands and adheres to the requirements of the study.
Who cannot join
- Subjects who meet any of the following exclusion criteria is not allowed to participate in the study:
- Subjects with diseases with abnormal clinical manifestations requiring exclusion, including but not limited to diseases of nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system.
- History of allergic diseases (including drug allergies and food allergies, etc.), and allergy to IMP4297 capsules or any component of the product.
- History of dysphagia or any gastrointestinal disease affecting drug absorption (as judged by the investigator).
- Subjects having experienced surgery within 3 months prior to screening, or having a surgery planned during the study period, and having received any surgery that may affect drug absorption (e.g., gastrectomy).
- Subjects who cannot tolerate venipuncture and who ever fainted during injection or at sight of blood.
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- Lactose intolerance (those who had diarrhea after drinking milk), or have special requirements for diet (e.g., vegetarians), or cannot tolerate standard high-fat breakfast.
- History of drug abuse within 6 months prior to screening, or a positive result on the urine drug screen (screening or baseline).
- Subjects who drink more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer, 150 mL of wine, or 45 mL of liquor) per week within 3 months prior to screening, or have a positive breath alcohol test (screening or baseline), or cannot abstain from alcohol during the trial.
- Subjects who smoke more than 5 cigarettes per day on average within 3 months prior to screening, or cannot stop using any tobacco products during the trial.
- Subjects who consumed excessive amount of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day on average during the 3 months prior to screening.
- Subjects who have participated in the clinical trial of other study drug/device within 3 months before the first administration of the study drug, or have participated in 3 or more clinical trials of drugs/devices in the past year; if the half-life of other study drugs is longer, the longer time interval is required, that is, 5 half-lives of the drug.
- Blood donation with blood components or significant blood loss (≥ 200 mL) within 3 months prior to screening; blood transfusion or use of blood products and blood biological products within 3 months prior to screening.
- Subjects who have received live vaccination within 4 weeks prior to screening.
- Used any drugs [e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; SSRI antidepressants, cimetidine, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines, antiviral drugs (such as saquinavir, etc.), calcium antagonists (such as diltiazem, verapamil, etc.), rifamycins (such as rifampicin, etc.)] that inhibit or induce hepatic metabolism of drugs within 28 days prior to taking study drug. If the half-life of a prior medication is longer, the required time interval will also be prolonged, that is, 5 half-lives of the drug, e.g. a 5-week washout period for phenobarbital.
- Used prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicines within 14 days prior to the first dose of study drug. If the half-life of a prior medication is longer, the required time interval will also be prolonged, that is, 5 half-lives of the drug. For over-the-counter medications that are not considered to affect the overall outcome of the study, limited use is permitted on a case-by-case basis after approval by the Sponsor and the Investigator.
- Positive for any of the hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or treponema pallidum antibody tests.
- Subjects with clinically significant abnormalities in vital signs (blood pressure, pulse and body temperature), complete physical examination, laboratory tests (hematology, blood chemistry and urinalysis) at screening as judged by the investigator; refer to normal range (including critical values) for vital signs: sitting systolic pressure 90-140 mmHg, diastolic pressure 60-90 mHg, pulse 60-100 beats/min, body temperature (ear temperature) 35.7-37.9℃, subjected to the comprehensive judgment by the investigator.
- Corrected QT interval (corrected according to Fridericia's formula, QTcF = QT/RR1/3) from 12-lead electrocardiogram (ECG) in supine position in the resting state (at least 5 min) at screening > 450 msec or QRS complex > 120 msec. If QTcF exceeds 450 msec or QRS exceeds 120 msec, 2 additional ECGs should be repeated, and the average of the 3 measured QTcF or QRS values are judged by the investigator to be clinically significant abnormalities.
- Subjects who cannot stop strenuous exercise within 48 hours before the first dose of the study drug and during the trial.
- Consumed any alcoholic, caffeine, chocolate, xanthine-rich food or beverage within 48 h before the first administration of the study drug; or unable to fast from these products during the trial.
- Subjects who cannot fast from grapefruit or grapefruit-related citrus (e.g., pomelo) fruits or juices within 7 days prior to the first dose of study drug and during the trial.
- Subjects or their partners have fertility plan during the whole process of the study and within 90 days after the last dose of the study drug, or are unwilling to take effective contraceptive measures (Appendix 1), or have sperm donation plan.
- Unwilling or unable to follow the protocol-specified lifestyle guidelines (e.g., dietary restrictions and activity requirements).
- Other acute or chronic medical or psychiatric condition that, in the judgment of the investigator, would make the subject inappropriate for this study, might increase the risk associated with participation in this study, or might interfere with the interpretation of study results.
- Other subjects who are not suitable to participate in the clinical trial as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fed condition
Read the detailed description
An open-label, randomized, single-dose, two-way crossover bioequivalence study is designed to determine whether single oral dose of IMP4297 capsules 100 mg (5 × 20 mg strength) and IMP4297 capsules 100 mg (10 × 10 mg strength) are bioequivalent in healthy Chinese male subjects under fed condition.
36 subjects (at least 30 completed) are planned to be enrolled.
- Conditions
- Solid Tumor
- Being tested
- IMP4297(20mg), IMP4297(10mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP4297(20mg)Drug
Single oral dose of IMP4297 administered under fasting conditions 5*20 mg capsules in first intervention period and 10*10 mg capsules in second intervention period (after washout period: at least 7 days)
IMP4297(10mg)Drug
Single oral dose of IMP4297 administered under fasting conditions 10*10 mg capsules in first intervention period and 5*20 mg capsules in second intervention period (after washout period: at least 7 days)
| Study group | Role | What they receive |
|---|---|---|
| IMP4297 first 5*20mg then 10*10mg | Experimental | Single oral dose of IMP4297 administered under fasting conditions 5*20 mg capsules in first intervention period and 10*10 mg capsules in second intervention period (after washout period: at least 7 days) Receives: Drug: IMP4297(20mg); Drug: IMP4297(10mg) |
| IMP4297 first 10*10mg then 5*20mg | Experimental | Single oral dose of IMP4297 administered under fasting conditions 10*10 mg capsules in first intervention period and 5*20 mg capsules in second intervention period (after washout period: at least 7 days) Receives: Drug: IMP4297(20mg); Drug: IMP4297(10mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.
Measured: 0-72 hours
AUC0-last
Area under the drug concentration-time curve from time 0 to the last time with quantifiable concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.
Measured: 0-72 hours
AUC0-inf
Area under the curve from time 0 to infinity. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start6 Jun 2022
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impact Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chuanling Li, Principal investigator, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391048
- Sponsor's protocol ID
- IMP4297-110-2
- Status last verified
- Sep 2025
- First submitted
- 20 May 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT05391048
- Acronym / sponsor ID
- IMP4297-110-2
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Impact Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 25 May 2022 (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.
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fed condition
Detailed description
An open-label, randomized, single-dose, two-way crossover bioequivalence study is designed to determine whether single oral dose of IMP4297 capsules 100 mg (5 × 20 mg strength) and IMP4297 capsules 100 mg (10 × 10 mg strength) are bioequivalent in healthy Chinese male subjects under fed condition.
36 subjects (at least 30 completed) are planned to be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMP4297 first 5*20mg then 10*10mg | Experimental | Drug: IMP4297(20mg), Drug: IMP4297(10mg)Single oral dose of IMP4297 administered under fasting conditions 5*20 mg capsules in first intervention period and 10*10 mg capsules in second intervention period (after washout period: at least 7 days) |
| IMP4297 first 10*10mg then 5*20mg | Experimental | Drug: IMP4297(20mg), Drug: IMP4297(10mg)Single oral dose of IMP4297 administered under fasting conditions 10*10 mg capsules in first intervention period and 5*20 mg capsules in second intervention period (after washout period: at least 7 days) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject fully understands the objective, nature, method of the trial and possible adverse reactions, voluntarily acts as a subject, signs the informed consent form before any study procedure, and ensures that any procedure is performed by himself/herself.
- Healthy Chinese male subjects aged 18 to 55 years (inclusive) at Screening.
- Body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive); body weight ≥ 50.0 kg.
- Subject is able to communicate well with the Investigator and understands and adheres to the requirements of the study.
Key exclusion criteria (26 listed)
- Subjects who meet any of the following exclusion criteria is not allowed to participate in the study:
- Subjects with diseases with abnormal clinical manifestations requiring exclusion, including but not limited to diseases of nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system.
- History of allergic diseases (including drug allergies and food allergies, etc.), and allergy to IMP4297 capsules or any component of the product.
- History of dysphagia or any gastrointestinal disease affecting drug absorption (as judged by the investigator).
- Subjects having experienced surgery within 3 months prior to screening, or having a surgery planned during the study period, and having received any surgery that may affect drug absorption (e.g., gastrectomy).
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 |
|---|---|---|
| IMP4297(20mg)Single oral dose of IMP4297 administered under fasting conditions 5*20 mg capsules in first intervention period and 10*10 mg capsules in second intervention period (after washout period: at least 7 days) | Drug | IMP4297 first 10*10mg then 5*20mg, IMP4297 first 5*20mg then 10*10mg |
| IMP4297(10mg)Single oral dose of IMP4297 administered under fasting conditions 10*10 mg capsules in first intervention period and 5*20 mg capsules in second intervention period (after washout period: at least 7 days) | Drug | IMP4297 first 10*10mg then 5*20mg, IMP4297 first 5*20mg then 10*10mg |
Primary outcome
Cmax
Time frame: 0-72 hours
Maximum concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.
AUC0-last
Time frame: 0-72 hours
Area under the drug concentration-time curve from time 0 to the last time with quantifiable concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.
AUC0-inf
Time frame: 0-72 hours
Area under the curve from time 0 to infinity. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose, before meal) and 1 hour, 2 hour, 3 hour, 4 hour, 4.5 hour, 5 hour, 5.5 hour, 6 hour, 7 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.
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 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Chuanling Li principal investigator
Xuzhou Central Hospital
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 IMP4297(20mg) and IMP4297(10mg) in people with Solid Tumor, run by Impact Therapeutics, Inc. 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 5 inclusion and 26 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 16 Sep 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: 0-72 hours). 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 16 Sep 2025.