Breast CancerPhase 1NCT06619873
A Clinical Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects
A Phase 1 study testing HRS-8080 in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the relative bioavailability of HRS-8080 in the fasted state in healthy adult subjects and to assess the impact of food on HRS-8080 PK for the Phase 3 capsule in healthy adult. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-8080
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 13 Nov 2024
- 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
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial;
- Between 18 and 45 years of age, inclusive;
- Female subjects with weight ≥ 45kg, male subjects with weight ≥50kg, body mass index (BMI) range 19 to 26 kg/m2, inclusive at Screening;
- Subjects of childbearing potential must agree to take contraceptive measures, and use requested contraceptive measures with their partners from signing the ICF to 6 months after the last dose. Female subjects must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating, and agree to avoid egg donation during the treatment period until 6 months after the last dose of the investigational drug.
Who cannot join
- Having a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator);
- Having a history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attack or any condition that may cause seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc.;
- History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization;
- History of stomach or intestinal surgery (including cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed;
- Clinically significant findings from medical history, 12-lead ECG, or vital signs;
- GFR < 90 ml/min/1.73 m2;
Show all 19Show fewer
- Having a QTc interval >470 msec for female and >450 msec for male;
- Positive hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) or human immunodeficiency virus (HIV) antibody screens;
- Having a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator; History of allergy to HRS-8080 or any of its excipients;
- The use or intent to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including prescription medication, over the counter medication and traditional Chinese medication, within 30 days prior to screening;
- The participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to screening;
- Participated in blood donation within 3 months before screening and donated ≥ 400 mL of blood or ≥ 400 mL of blood loss; Participated in blood donation within 1 month before screening and donated blood volume ≥ 200 mL or blood loss ≥ 200 mL; Those who have received blood transfusions or used blood products within 3 months before screening;
- Positive test for selected drugs of abuse at Screening;
- The use of drugs of abuse (including opioids) within3 months of Screening;
- having a history of alcoholism or heavy smoker within 3 month prior screening; unable to abstain from smoking or alcohol during the trial period;
- Poor peripheral venous access;
- The need to follow a special diet and unable to consume the high-fat meal;
- Pregnant or Breastfeeding;
- In the opinion of the Investigator or Sponsor, are unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, 230001
About this study
Official title: A Phase 1, Open-Label, Single-Dose, Randomized, Four-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects
The study is being conducted to evaluate the relative bioavailability of HRS-8080 in the fasted state in healthy adult subjects and to assess the impact of food on HRS-8080 PK for the Phase 3 capsule in healthy adult.
- Conditions
- Breast Cancer
- Being tested
- HRS-8080
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8080Drug
Medication regimen A
Drug:
600mg, Old process tablets，NPO
Medication regimen B
Drug:
600mg, New process tablets，NPO
Medication regimen C
Drug:
600mg, New process tablets，PC.，low-fat diet
Medication regimen D
Drug:
600mg, New process tablets，PC.，high-fat diet
| Study group | Role | What they receive |
|---|---|---|
| Medication regimen A-D-B-C | Experimental | Not described Receives: Drug: HRS-8080 |
| Medication regimen B-A-C-D | Experimental | Not described Receives: Drug: HRS-8080 |
| Medication regimen C-B-D-A | Experimental | Not described Receives: Drug: HRS-8080 |
| Medication regimen D-C-A-B | Experimental | Not described Receives: Drug: HRS-8080 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 0 hour-48 hour
AUC0-t
Measured: 0 hour-48 hour
AUC0-inf
Measured: 0 hour-48 hour
Secondary outcomes (4)
Tmax
Measured: 0 hour-48 hour
T1/2
Measured: 0 hour-48 hour
CL/F
Measured: 0 hour-48 hour
Vz/F
Measured: 0 hour-48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06619873
- Sponsor's protocol ID
- HRS-8080-102
- Status last verified
- May 2026
- First submitted
- 25 Sep 2024
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose, Randomized, Four-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06619873
- Acronym / sponsor ID
- HRS-8080-102
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 1 Oct 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 study is being conducted to evaluate the relative bioavailability of HRS-8080 in the fasted state in healthy adult subjects and to assess the impact of food on HRS-8080 PK for the Phase 3 capsule in healthy adult.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medication regimen A-D-B-C | Experimental | Drug: HRS-8080 |
| Medication regimen B-A-C-D | Experimental | Drug: HRS-8080 |
| Medication regimen C-B-D-A | Experimental | Drug: HRS-8080 |
| Medication regimen D-C-A-B | Experimental | Drug: HRS-8080 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial;
- Between 18 and 45 years of age, inclusive;
- Female subjects with weight ≥ 45kg, male subjects with weight ≥50kg, body mass index (BMI) range 19 to 26 kg/m2, inclusive at Screening;
- Subjects of childbearing potential must agree to take contraceptive measures, and use requested contraceptive measures with their partners from signing the ICF to 6 months after the last dose. Female subjects must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating, and agree to avoid egg donation during the treatment period until 6 months after the last dose of the investigational drug.
Key exclusion criteria (19 listed)
- Having a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator);
- Having a history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attack or any condition that may cause seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc.;
- History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization;
- History of stomach or intestinal surgery (including cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed;
- Clinically significant findings from medical history, 12-lead ECG, or vital signs;
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-8080Medication regimen A Drug: 600mg, Old process tablets，NPO Medication regimen B Drug: 600mg, New process tablets，NPO Medication regimen C Drug: 600mg, New process tablets，PC.，low-fat diet Medication regimen D Drug: 600mg, New process tablets，PC.，high-fat diet | Drug | Medication regimen A-D-B-C, Medication regimen B-A-C-D, Medication regimen C-B-D-A, Medication regimen D-C-A-B |
Primary outcome
Cmax
Time frame: 0 hour-48 hour
AUC0-t
Time frame: 0 hour-48 hour
AUC0-inf
Time frame: 0 hour-48 hour
4 secondary outcomes
Tmax
Time frame: 0 hour-48 hour
T1/2
Time frame: 0 hour-48 hour
CL/F
Time frame: 0 hour-48 hour
Vz/F
Time frame: 0 hour-48 hour
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 27 May 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-8080 in people with Breast Cancer, 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 19 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 27 May 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?
Cmax (time frame: 0 hour-48 hour). 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 27 May 2026.