Malignant Solid TumorPhase 1NCT07639905
A Clinical Study Comparing the Bioavailability of HRS-2189 Tablets
A Phase 1 study testing HRS-2189 Tablet in people with Malignant Solid Tumor, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- HRS-2189 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2026to 6 Aug 2026
- 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
- Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.
- Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).
- Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 [BMI = weight (kg) / height2 (m2)] (including both endpoints).
- Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.
Who cannot join
- Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.
- Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.
- Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients.
- Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.
- Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug.
- Those who smoked at least 5 cigarettes per day for the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial, or those with a positive urine nicotine screening result.
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- Those who frequently consumed alcohol within the six months prior to the trial, namely those who drank ≥ 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 150 mL of wine), or those who were unable to give up drinking during the trial, or those with a positive blood alcohol test result.
- The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, imaging and ultrasound tests during the screening period were abnormal and had clinical significance. Based on the judgment of the researchers, they were not suitable to participate in this study.
- Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
- Pregnant and lactating women.
- Those with a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
- Due to other reasons, after the researchers' evaluation, participants who were deemed unsuitable to participate in this study were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Single-center, Single-dose, Randomized, Open-label, Two-period, Crossover Clinical Study on the Bioavailability and Safety of the New and Old Formulations HRS-2189 Tablets in Healthy Subjects
This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.
- Conditions
- Malignant Solid Tumor
- Being tested
- HRS-2189 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2189 TabletDrug
HRS-2189 tablet, oral.
| Study group | Role | What they receive |
|---|---|---|
| HRS-2189 of new process | Experimental | HRS-2189 of new process. Receives: Drug: HRS-2189 Tablet |
| HRS-2189 of old process | Experimental | HRS-2189 of old process. Receives: Drug: HRS-2189 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: Day1 - Day37.
From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration (AUC0-t)
Measured: Day1 - Day37.
Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)
Measured: Day1 - Day37.
Secondary outcomes (5)
Time to maximum plasma concentration (Tmax)
Measured: Day1 - Day37.
Terminal half-life (t1/2)
Measured: Day1 - Day37.
Apparent clearance (CL/F)
Measured: Day1 - Day37.
Apparent volume of distribution (Vz/F)
Measured: Day1 - Day37.
Incidence and severity of adverse events (AEs)
Safety measure.
Measured: Day1 - Day37.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start19 Jun 2026
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a single-center, single-dose, randomized, open-label, two sequences, two period and crossover design.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639905
- Sponsor's protocol ID
- HRS-2189-102
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-dose, Randomized, Open-label, Two-period, Crossover Clinical Study on the Bioavailability and Safety of the New and Old Formulations HRS-2189 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07639905
- Acronym / sponsor ID
- HRS-2189-102
- Conditions
- Malignant Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 10 Jun 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 study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a single-center, single-dose, randomized, open-label, two sequences, two period and crossover design.
| Arm | Type | Receives |
|---|---|---|
| HRS-2189 of new process | Experimental | Drug: HRS-2189 TabletHRS-2189 of new process. |
| HRS-2189 of old process | Experimental | Drug: HRS-2189 TabletHRS-2189 of old process. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.
- Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).
- Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 [BMI = weight (kg) / height2 (m2)] (including both endpoints).
- Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.
Key exclusion criteria (12 listed)
- Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.
- Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.
- Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients.
- Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.
- Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug.
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 |
|---|---|---|
| HRS-2189 TabletHRS-2189 tablet, oral. | Drug | HRS-2189 of new process, HRS-2189 of old process |
Primary outcome
The maximum plasma concentration (Cmax)
Time frame: Day1 - Day37.
From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration (AUC0-t)
Time frame: Day1 - Day37.
Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)
Time frame: Day1 - Day37.
5 secondary outcomes
Time to maximum plasma concentration (Tmax)
Time frame: Day1 - Day37.
Terminal half-life (t1/2)
Time frame: Day1 - Day37.
Apparent clearance (CL/F)
Time frame: Day1 - Day37.
Apparent volume of distribution (Vz/F)
Time frame: Day1 - Day37.
Incidence and severity of adverse events (AEs)
Time frame: Day1 - Day37.
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 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 HRS-2189 Tablet in people with Malignant Solid Tumor, run by Shandong Suncadia Medicine 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 4 inclusion and 12 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 21 Sep 2026. 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?
The maximum plasma concentration (Cmax) (time frame: Day1 - Day37.). 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 21 Sep 2026.