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New breast cancer Drug's absorption tested in healthy volunteers

NCT ID NCT06619873

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested the drug HRS-8080 in 24 healthy adults to see how well it is absorbed and whether food changes its levels in the body. Participants took single doses under different conditions, including fasting and with low- or high-fat meals. The results will help design future trials for breast cancer treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS-8080
What this could lead to
If successful, this study could help determine the best way to take HRS-8080 in future trials for breast cancer.
What could go wrong
This is a very early, small study in healthy people, not patients. It only measures how the drug moves through the body, not whether it works against cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Oct 2024

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230001, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.