Venous Thromboembolism (VTE)Phase 1NCT07786779
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of YKYY033 Injection
A Phase 1 study testing YKYY033 Injection in people with Venous Thromboembolism (VTE), run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
A phase 1 study to evaluate the safety and tolerability of a single administration of YKYY033 injection in healthy adult participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism (VTE)
- What is being tested?
- YKYY033 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 1 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
- Participant must be between 18 and 55 years of age (inclusive), male or female.
- 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.
Who cannot join
- 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.
- 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.
- 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.
- 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.
- 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.
- Evidence of acute febrile illness or active infection within 7 days prior to administration.
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- 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.
- 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.
- 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.
- 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.
- Any one of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody and HIV antibody was positive during screening.
- Pregnant women (with positive serum pregnancy results) and lactating women during screening.
- Those who have special dietary requirements and cannot accept unified dietary arrangements during the study.
- 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.
- 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.
- 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.
- There is any previous history of small interfering RNA (siRNA) or antisense oligonucleotides (ASO) drug therapy (including clinical trials).
- Those who use anticoagulant or thrombotic drugs (such as warfarin, vitamin K1, etc.) within 4 weeks before administration or during the trial study.
- 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
- Received any vaccine within 8 weeks prior to administration, or planned to receive the vaccine during the study period.
- Have participated in any other clinical trials within the past 3 months prior to screening.
- 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.
- History of drug allergy or any severe allergic disease.
- Difficulty in venous blood collection or intolerance to venipuncture, or history of needle and blood dizziness.
- Due to other reasons, the study may not be completed, or it may be deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100142
Haiyan Li, 010-68966677-8507
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of YKYY033 Injection in Chinese Healthy Adult Participants
A phase 1 study to evaluate the safety and tolerability of a single administration of YKYY033 injection in healthy adult participants
Read the detailed description
This is a randomized, double-blind, ascending-dose Phase 1 clinical study to investigate the safety and tolerability of YKYY033 when administered in healthy adult male and female participants
- Conditions
- Venous Thromboembolism (VTE)
- Being tested
- YKYY033 Injection, YKYY033 Placebo
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKYY033 InjectionDrug
subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 injection
YKYY033 PlaceboDrug
subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 Placebo
| Study group | Role | What they receive |
|---|---|---|
| YKYY033 group | Active comparator | Not described Receives: Drug: YKYY033 Injection |
| YKYY033 Placebo group | Placebo comparator | Not described Receives: Drug: YKYY033 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events(AEs)
Measured: within 337 days after administration
Serious adverse events (SAEs)
Measured: within 337days after administration
Injection site reaction
Measured: within 48 hours after administration
Secondary outcomes (7)
Cmax（Peak plasma concentration）
Measured: Pre-dose to 24 hours after administration
AUC（Area under the plasma concentration versus time curve）
Measured: Pre-dose to 24 hours after administration
Tmax（Time to maximum plasma concentration）
Measured: Pre-dose to 24 hours after administration
T1/2（Half-Life）
Measured: Pre-dose to 24 hours after administration
FXI (Coagulation Factor XI) antigen level
Measured: within 337 days after administration
FXI (Coagulation Factor XI) coagulation activity
Measured: within 337 days after administration
The time between the start of the q wave and the end of the t wave on an electrocardiogram/Corrected QT interval（QT/QTc） in 12-lead electrocardiogram (ECG)
Measured: within 337 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start10 Jul 2026
- Primary completion10 Nov 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786779
- Sponsor's protocol ID
- CLSP-YKYY033-Z01
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of YKYY033 Injection in Chinese Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07786779
- Acronym / sponsor ID
- CLSP-YKYY033-Z01
- Conditions
- Venous Thromboembolism (VTE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1 study to evaluate the safety and tolerability of a single administration of YKYY033 injection in healthy adult participants
Detailed description
This is a randomized, double-blind, ascending-dose Phase 1 clinical study to investigate the safety and tolerability of YKYY033 when administered in healthy adult male and female participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YKYY033 group | Active comparator | Drug: YKYY033 Injection |
| YKYY033 Placebo group | Placebo comparator | Drug: YKYY033 Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
- Participant must be between 18 and 55 years of age (inclusive), male or female.
- 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.
Key exclusion criteria (25 listed)
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YKYY033 Injectionsubcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 injection | Drug | YKYY033 group |
| YKYY033 Placebosubcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 Placebo | Drug | YKYY033 Placebo group |
Primary outcome
Adverse events(AEs)
Time frame: within 337 days after administration
Serious adverse events (SAEs)
Time frame: within 337days after administration
Injection site reaction
Time frame: within 48 hours after administration
7 secondary outcomes
Cmax（Peak plasma concentration）
Time frame: Pre-dose to 24 hours after administration
AUC（Area under the plasma concentration versus time curve）
Time frame: Pre-dose to 24 hours after administration
Tmax（Time to maximum plasma concentration）
Time frame: Pre-dose to 24 hours after administration
T1/2（Half-Life）
Time frame: Pre-dose to 24 hours after administration
FXI (Coagulation Factor XI) antigen level
Time frame: within 337 days after administration
FXI (Coagulation Factor XI) coagulation activity
Time frame: within 337 days after administration
The time between the start of the q wave and the end of the t wave on an electrocardiogram/Corrected QT interval（QT/QTc） in 12-lead electrocardiogram (ECG)
Time frame: within 337 days after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YKYY033 Injection in people with Venous Thromboembolism (VTE), run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Zhou (+86 18606417018, zhouyuting@bjykkc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events(AEs) (time frame: within 337 days after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.