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Healthy volunteers to test new formulation of breast cancer drug HRS-6209
NCT ID NCT07610148
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This early-stage trial will test two different versions of the experimental drug HRS-6209 in 21 healthy Chinese adults. The goal is to see how the body absorbs the old and new capsule forms, and whether a high-fat meal affects absorption. No treatment benefit is expected for participants, as this is purely a pharmacokinetic and safety study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-6209 (an experimental drug for breast cancer)
- What this could lead to
- If successful, this could help develop a better formulation of HRS-6209 for future breast cancer treatment.
- What could go wrong
- This is a very early phase 1 study in healthy people, not patients. It only measures drug levels and safety, not whether the drug works against cancer. Many drugs fail in later trials.
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
-
21 people
The number who actually took part.
- Started
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Jun 2026
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. Healthy men and women aged 18 to 50 years old at informed consent signing. 2. Male body weight ≥ 50 kg, female ≥ 45 kg; BMI 19 to 26 kg/m² at screening and baseline. 3. Have no clinically significant abnormalities at screening and baseline. 4. Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 6 months after the last dose (abstinence or highly effective contraception); no sperm/egg donation. Exclusion Criteria: 1. Current or history of clinically significant disorders of any major system (urinary, circulatory, endocrine, nervous, digestive, respiratory, hematologic, immune, psychiatric, metabolic, etc.) or any other condition that may interfere with study results per investigator judgment. 2. History of epilepsy, including febrile seizures in childhood, loss of consciousness, transient ischemic attack, or any condition predisposing to seizures (e.g., cerebrovascular disease, brain injury, stroke, brain cancer). 3. Clinically significant acute illness within 1 month prior to screening, including fever or febrile symptoms, viral, bacterial (including upper respiratory tract infection), or non-cutaneous fungal infections. 4. Any surgery within 6 months prior to study, or planned surgery during study period; prior surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, bariatric surgery) or affecting liver function. 5. Positive for anti-HCV, anti-HIV, HBsAg, or syphilis antibodies. 6. Blood donation or loss ≥ 400 mL within 3 months, or ≥ 200 mL within 1 month prior to screening; blood transfusion or use of blood products within 3 months prior to screening. 7. Long-term use (\> 7 consecutive days) of hepatotoxic drugs within 6 months; use of any drug affecting liver metabolism within 1 month prior to first dose; use of other drugs (prescription, OTC, herbal, vitamins, calcium, etc.) within 14 days prior to first dose, other than those affecting liver metabolism. 8. Participation in another clinical trial with investigational drug within 3 months; vaccination within 3 months prior to screening or planned during study. 9. History of drug abuse/dependence; positive urine drug screen at screening. 10. History of heavy smoking (average ≥ 5 cigarettes/day) within 3 months prior to screening; inability to abstain from any tobacco products during study; positive smoke screen. 11. Alcoholism (average daily intake exceeding: \> 14 units/week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine); positive alcohol screen; inability to abstain from alcohol during study. 12. Special dietary requirements or inability to comply with standardized meals. 13. Dysphagia, difficulty with venous blood collection, or inability to tolerate intensive blood sampling. 14. Other conditions that, in the investigator's judgment, make the participant unsuitable for 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
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Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001, China
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