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Healthy volunteers to test new formulation of breast cancer drug HRS-6209

NCT ID NCT07610148

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Jun 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

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 50 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. 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

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, 350001, China

More trials for these conditions

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