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CompletedNCT06619873Updated May 27, 2026

A Clinical Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects

A Phase 1 interventional study of HRS-8080 in Breast Cancer, sponsored by Shandong Suncadia Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 24 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial;
  2. Between 18 and 45 years of age, inclusive;
  3. Female subjects with weight ≥ 45kg, male subjects with weight ≥50kg, body mass index (BMI) range 19 to 26 kg/m2, inclusive at Screening;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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);
  2. 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.;
  3. History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization;
  4. 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;
  5. Clinically significant findings from medical history, 12-lead ECG, or vital signs;
  6. GFR \< 90 ml/min/1.73 m2;
  7. Having a QTc interval >470 msec for female and >450 msec for male;
  8. Positive hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) or human immunodeficiency virus (HIV) antibody screens;
  9. 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;
  10. 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;
  11. 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;
  12. 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;
  13. Positive test for selected drugs of abuse at Screening;
  14. The use of drugs of abuse (including opioids) within3 months of Screening;
  15. having a history of alcoholism or heavy smoker within 3 month prior screening; unable to abstain from smoking or alcohol during the trial period;
  16. Poor peripheral venous access;
  17. The need to follow a special diet and unable to consume the high-fat meal;
  18. Pregnant or Breastfeeding;
  19. In the opinion of the Investigator or Sponsor, are unsuitable for inclusion in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Medication regimen A-D-B-C

    Drug: HRS-8080

  • Experimental
    Medication regimen B-A-C-D

    Drug: HRS-8080

  • Experimental
    Medication regimen C-B-D-A

    Drug: HRS-8080

  • Experimental
    Medication regimen D-C-A-B

    Drug: HRS-8080

Interventions

  • DrugHRS-8080

    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

06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: 0 hour-48 hour

  2. AUC0-t

    Time frame: 0 hour-48 hour

  3. AUC0-inf

    Time frame: 0 hour-48 hour

Secondary outcomes

  1. Tmax

    Time frame: 0 hour-48 hour

  2. T1/2

    Time frame: 0 hour-48 hour

  3. CL/F

    Time frame: 0 hour-48 hour

  4. Vz/F

    Time frame: 0 hour-48 hour

07

Study locations

1 site
  • The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
    Hefei, Anhui 230001, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06619873
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Oct 10, 2024
Primary completion
Nov 13, 2024
Completion
Nov 13, 2024
Last update
May 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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