Healthy volunteers needed to test new version of cancer drug
NCT ID NCT07639905
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new formulation of the cancer drug HRS-2189 in 28 healthy adults aged 18-45. The goal is to compare how the body absorbs the new versus the old tablet version and to check for safety. Participants will take a single dose of each formulation in random order, with a break in between. This study does not aim to treat cancer, but to gather important information for future drug development.
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
-
About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 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 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 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. Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements. 2. Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends). 3. Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 \[BMI = weight (kg) / height2 (m2)\] (including both endpoints). 4. Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Exclusion Criteria: 1. Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results. 2. Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period. 3. Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients. 4. Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests. 5. Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug. 6. Those who smoked at least 5 cigarettes per day for the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial, or those with a positive urine nicotine screening result. 7. Those who frequently consumed alcohol within the six months prior to the trial, namely those who drank ≥ 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 150 mL of wine), or those who were unable to give up drinking during the trial, or those with a positive blood alcohol test result. 8. The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, imaging and ultrasound tests during the screening period were abnormal and had clinical significance. Based on the judgment of the researchers, they were not suitable to participate in this study. 9. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody. 10. Pregnant and lactating women. 11. Those with a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection. 12. Due to other reasons, after the researchers' evaluation, participants who were deemed unsuitable to participate in this study were excluded.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Malignant solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink tumors that resist other treatments?
- Ear acupressure: a new weapon against chemotherapy side effects?
- Can a Custom-Made immune cell vaccine turn the tide against solid tumors?
- Can a new tracer light up tumors better than standard PET scans?
- Personalized weight loss coaching could help cancer survivors shed pounds
- New PET tracer aims to light up tumors, but trial stalls