ClinicalTrials.gg
RecruitingNCT07786779Updated Aug 26, 2026

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of YKYY033 Injection

A Phase 1 interventional study of YKYY033 Injection and YKYY033 Placebo in Venous Thromboembolism (VTE), sponsored by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. (part of Youcare Pharmaceutical Group Co., Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 62 studies in Venous Thromboembolism with a site in China — 21 open to participants now, 23 under way, 2 of them phase 3. Venous Thromboembolism · China.

Planned enrollment
33rd of 33
40 · median 530
Started
2026
with 4 others
Phase 1
Only one
of the 62
Primary completion
2027-11
later than 17 of 22 live
Registered
61st of 62
by date

Among the 62 studies in Venous Thromboembolism with a site in China, this one is the 33rd largest by planned enrollment of the 33 interventional ones, is one of 5 that started in 2026, is the only one in phase 1, reaches primary completion later than 17 of the 22 other live ones, and was the 61st registered.

By phase

62 studies; the count open now beside each. This study's row is marked.

Observational29 · 11 open
Phase 316 · 2 open
No phase10 · 5 open
Phase 44 · 2 open
Phase 22 · 0 open
Phase 1this study1 · 1 open

By the year they started

First in 2001; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 530 across the 33 interventional studies, 1,174 across the 29 observational. Of the 31 that completed or were terminated, 5 (16%) have results posted.

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02

Study summary

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

03

Conditions studied

  • Venous Thromboembolism (VTE)
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant must voluntarily consent to participate in this study and provide their written 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 (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 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

Exclusion Criteria:

  1. History or present history of 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 ; 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 measurements.
  4. History of intolerance to SC injection or significant abdominal scars that may significantly affect the administration of the 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 (), 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 surface antigen, antibody, treponema pallidum antibody and 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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    YKYY033 group

    Drug: YKYY033 Injection

  • Placebo comparator
    YKYY033 Placebo group

    Drug: YKYY033 Placebo

Interventions

  • DrugYKYY033 Injection

    subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 injection

  • DrugYKYY033 Placebo

    subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 Placebo

06

What researchers measure

Primary outcomes

  1. Adverse events(AEs)

    Time frame: within 337 days after administration

  2. Serious adverse events (SAEs)

    Time frame: within 337days after administration

  3. Injection site reaction

    Time frame: within 48 hours after administration

Secondary outcomes

  1. Cmax(Peak plasma concentration)

    Time frame: Pre-dose to 24 hours after administration

  2. AUC(Area under the plasma concentration versus time curve)

    Time frame: Pre-dose to 24 hours after administration

  3. Tmax(Time to maximum plasma concentration)

    Time frame: Pre-dose to 24 hours after administration

  4. T1/2(Half-Life)

    Time frame: Pre-dose to 24 hours after administration

  5. FXI (Coagulation Factor XI) antigen level

    Time frame: within 337 days after administration

  6. FXI (Coagulation Factor XI) coagulation activity

    Time frame: within 337 days after administration

  7. 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

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing Municipality 100142, China
    Recruiting
    • Haiyan Li · Contact010-68966677-8507
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Nov 2027, 16 months after the start.

Of 16 phase 1 interventional studies under Venous Thromboembolism, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2026
First posted
Aug 26, 2026
StartActual
Jul 10, 2026
Primary completionEst.
Nov 10, 2027
CompletionEst.
Jul 1, 2028
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07786779
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Jul 10, 2026
Primary completion
Nov 10, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Aug 26, 2026

Study contacts

Yuting Zhou
Contact
zhouyuting@bjykkc.com
+86 18606417018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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