One shot to stop blood clots? new injection put to the test
NCT ID NCT07786779
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a single injection of an experimental drug called YKYY033 is safe and tolerable in healthy adults aged 18 to 55. The study will also measure how the drug moves through the body and how it affects a clotting factor. If successful, YKYY033 could one day help prevent venous thromboembolism, a condition where blood clots form in veins.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YKYY033 injection, an experimental drug given as a single subcutaneous shot
- What this could lead to
- If safe, YKYY033 could become a new way to prevent dangerous blood clots (venous thromboembolism) with a single injection.
- What could go wrong
- This is an early, small Phase 1 study in healthy volunteers, so it may not work or be safe in patients. Side effects and injection-site reactions are possible.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Jul 2028
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 55 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. Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures. 2. Participant must be between 18 and 55 years of age (inclusive), male or female. 3. Participant's body mass index (BMI) must be between 19 and 28 kg/m\^2 (inclusive). The body weight should be ≥50 kg for men and ≥45 kg for women. 4.Participants (including their spouses or partners) are willing to sign the informed consent form and have no plans to have children or donate sperm (eggs) within 6-12 months after administration, and voluntarily take effective contraceptive measures (including abstinence, condoms, intrauterine devices, etc.) 5. Participants are able to communicate effectively with the investigators and understand and comply with the requirements of this study. Exclusion Criteria: 1. History or present history of clinically significant hematological, circulatory, respiratory, digestive, urinary, neurological, immune, endocrine, or psychiatric disorders, or other diseases that investigators believe may affect the safety of participants in the study. 2. History or evidence of any abnormal bleeding or coagulation disorders, or there may be coagulation dysfunction (such as Von Willebrand disease, hemophilia), long-term or unexplained clinically significant bleeding, or evidence of frequent unexplained bruising or thrombosis, or have a history of spontaneous bleeding, or diseases with increased risk of bleeding (such as active and meaningful peptic ulcers judged by investigators. 3. Individuals with a history of cardiovascular diseases, including but not limited to myocardial infarction, congenital heart disease, heart valve disease, coronary revascularization, angina, heart failure, and other heart diseases and arrhythmias that may cause QT prolongation; Or there may be other risk factors that lead to tip twisting ventricular tachycardia; Or there may be a history of atrial flutter, atrial fibrillation, or other conditions that may interfere with electrocardiogram measurements. 4. History of intolerance to SC injection or significant abdominal scars that may significantly affect the administration of the investigational drug or the assessment of local safety. 5. Major surgery within 6 months prior to screening (such as heart, brain, liver, kidney, knee replacement, or other surgeries that researchers believe may affect the conduct of the trial), or have undergone surgeries that may affect drug absorption, distribution, metabolism or excretion, or plan to undergo surgery during the study. 6. Evidence of acute febrile illness or active infection within 7 days prior to administration. 7. An abnormal result judged by the physician during the screening period to be clinically significant in physical examination, vital signs examination, laboratory examinations (blood routine, urine routine, blood biochemistry) or other auxiliary examination results. 8. The coagulation time (APTT), prothrombin time (PT), or international normalized ratio (INR) are outside the normal range specified by the laboratory (except for those who are mildly below the lower limit of normal (LLN) and have no other coagulation function indicators combined with abnormalities) during the screening period. 9. An abnormal result judged by the physician to be clinically significant in the 12-lead electrocardiogram, or the adjusted QTc interval ≥450 ms for males and ≥470 ms for females, or PR interval ≥210 ms, or QRS interval ≥210 ms. 10. During the screening process, any of the urine drug abuse screening results were positive, or screen for individuals with a history of drug abuse or drug use within the past 3 years. 11. Any one of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody and HIV antibody was positive during screening. 12. Pregnant women (with positive serum pregnancy results) and lactating women during screening. 13. Those who have special dietary requirements and cannot accept unified dietary arrangements during the study. 14. Drink strong tea, coffee, and/or caffeinated beverages daily (≥ 8 cups/day, 1 cup=250mL) within 3 months before administration; Or ingested any food or drink containing caffeine (such as coffee, strong tea, cola, chocolate, etc.) or xanthine (such as animal viscera, sardine, soy products, etc.) within 48 hours before randomization. 15. Smoking more than 5 cigarettes per day within the first 3 months of screening; During hospitalization, the use of any tobacco products (such as cigarettes, electronic cigarettes) cannot be stopped. 16. The average weekly alcohol consumption within the first 3 months of screening is greater than 14 units (1 unit of alcohol ≈ 355 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine); Or the alcohol breath test result is positive; Or randomly select individuals who cannot abstain from alcohol within the first 48 hours and during hospitalization. 17. There is any previous history of small interfering RNA (siRNA) or antisense oligonucleotides (ASO) drug therapy (including clinical trials). 18. Those who use anticoagulant or thrombotic drugs (such as warfarin, vitamin K1, etc.) within 4 weeks before administration or during the trial study. 19. Participants who have used any drugs that investigators believe may affect the pharmacokinetic characteristics of the investigational drug within 2 weeks prior to administration, including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, vitamins, etc 20. Received any vaccine within 8 weeks prior to administration, or planned to receive the vaccine during the study period. 21. Have participated in any other clinical trials within the past 3 months prior to screening. 22. Blood donation or significant blood loss (\>400 mL) within the first 3 months of screening; Or receiving blood transfusions or using blood products (such as albumin); Or plan to donate blood during the study. 23. History of drug allergy or any severe allergic disease. 24. Difficulty in venous blood collection or intolerance to venipuncture, or history of needle and blood dizziness. 25. Due to other reasons, the study may not be completed, or it may be deemed unsuitable for inclusion by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Venous thromboembolism (VTE) are added.
By submitting, you agree to our Terms of use
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
-
Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which blood thinner is safer for lung clots? a Head-to-Head test
- Could a 30-Day blood thinner regimen prevent clots after spine cancer surgery?
- New antibody drugs aim to prevent Catheter-Related blood clots
- New tool aims to help blood clot patients choose wisely on blood thinners
- Blood thinner levels under microscope to prevent clots and bleeding
- Blood thinners after birth: could they save lives of new moms at moderate risk?