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

NCT07786779 | Recruiting Phase 1

• 1 other identifier: CLSP-YKYY033-Z01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 1 study to evaluate the safety and tolerability of a single administration of YKYY033 injection in healthy adult participants

Conditions

Venous Thromboembolism (VTE)

Outcome Measures

Primary Outcomes (3)

• Adverse events(AEs)

  within 337 days after administration

• Serious adverse events (SAEs)

  within 337days after administration

• Injection site reaction

  within 48 hours after administration

Secondary Outcomes (7)

• Cmax（Peak plasma concentration）

  Pre-dose to 24 hours after administration

• AUC（Area under the plasma concentration versus time curve）

  Pre-dose to 24 hours after administration

• Tmax（Time to maximum plasma concentration）

  Pre-dose to 24 hours after administration

• T1/2（Half-Life）

  Pre-dose to 24 hours after administration

• FXI (Coagulation Factor XI) antigen level

  within 337 days after administration

Study Arms (2)

YKYY033 group

ACTIVE COMPARATOR

Drug: YKYY033 Injection

YKYY033 Placebo group

PLACEBO COMPARATOR

Drug: YKYY033 Placebo

Interventions

YKYY033 Injection DRUG

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

YKYY033 group

YKYY033 Placebo DRUG

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

YKYY033 Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• ．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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuting Zhou

CONTACT

+86 18606417018; zhouyuting@bjykkc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)