Phase 1 Breast Cancer Trial, Not Yet Recruiting NCT07610148 Sponsor: Jiangsu HengRui Medicine Co., Ltd. Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Not Yet Recruiting

NCT07610148
Not Yet Recruiting Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Healthy men and women between 18 and 50 years old at the time of signing the consent form.
  • Men who weigh at least 50 kg and women who weigh at least 45 kg, with a body mass index (a measure of body weight relative to height) between 19 and 26 at the screening and baseline visits.
  • People who have no medically significant abnormal test results or findings at the screening and baseline visits.
  • People who are capable of having children must use reliable contraception (or abstain from sex) starting 2 weeks before signing the consent form and continuing until 6 months after the last dose, and must not donate sperm or eggs during this time.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have, or have a history of, significant health problems affecting major body systems — such as the urinary, circulatory, hormonal, nervous, digestive, respiratory, blood, immune, or mental health systems — or any other condition the trial doctor considers likely to affect the study results.
  • People with a history of epilepsy, childhood seizures caused by fever, loss of consciousness, mini-strokes, or any condition that increases the risk of seizures (such as stroke, brain injury, or brain cancer).
  • People who have had a significant illness in the month before screening, including fever, viral or bacterial infections (such as upper respiratory tract infections), or fungal infections not limited to the skin.
  • People who have had surgery in the 6 months before the study, who have surgery planned during the study, or who have previously had surgery that affects how the gut absorbs substances or how the liver functions (such as stomach removal, bowel resection, or weight-loss surgery).
  • People who test positive for hepatitis C antibodies, HIV antibodies, hepatitis B surface antigen, or syphilis antibodies.
  • People who have donated or lost 400 mL or more of blood in the 3 months before screening, or 200 mL or more in the month before screening, or who have received a blood transfusion or blood products in the 3 months before screening.
  • People who have used medications known to harm the liver for more than 7 consecutive days in the 6 months before the study, used any drug that affects how the liver processes substances in the month before the first dose, or used any other medications (including prescription, over-the-counter, herbal remedies, vitamins, or calcium supplements) in the 14 days before the first dose — except those affecting liver metabolism (confirm with trial site).
  • People who have taken part in another clinical trial involving an experimental drug in the 3 months before screening, or who have received a vaccine in the 3 months before screening or plan to receive one during the study.
  • People with a history of drug misuse or dependence, or who test positive on a urine drug screen at screening.
  • People who have smoked an average of 5 or more cigarettes per day in the 3 months before screening, who cannot completely avoid all tobacco products during the study, or who test positive on a smoke screen test.
  • People who drink heavily (more than 14 units of alcohol per week on average — where 1 unit equals approximately 285 mL of beer, 25 mL of spirits, or 100 mL of wine), who test positive on an alcohol screen, or who cannot avoid alcohol completely during the study.
  • People who have special dietary needs or who are unable to follow the standardised meals required by the study.
  • People who have difficulty swallowing, difficulty with blood being drawn from a vein, or who are unable to tolerate the frequent blood samples required during the study.
  • People who, in the trial doctor's judgement, are considered unsuitable for the study for any other reason.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026

Contact this trial

Phone: +86-0518-82342973

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 June 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Area under the concentration time curve (AUC); Maximum Plasma Concentration (Cmax)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov