A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyna… (NCT07638098) | Clinical Trial Compass
CompletedPhase 1
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZKLJ02 Injection in Healthy Chinese Research Participants
China50 participantsStarted 2025-08-11
Plain-language summary
A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous administration of ZKLJ02 injection in healthy Chinese research participants
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to provide informed consent and willing to comply with the study procedures;
. Age between 18 and 45 years (inclusive), regardless of gender;
. No clinically significant past or current medical history of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, psychiatric, or metabolic disorders, as determined by the investigator;
. Physical examination, laboratory tests, 12-lead ECG, and vital signs are all normal or show abnormalities that are not clinically significant;
. Body mass index (BMI) between 19.0 and 26.0 kg/m\^2 (inclusive); body weight not less than 50 kg for males and not less than 45 kg for females;
. Men with reproductive potential and women of childbearing potential must have no plans for pregnancy, sperm donation, or oocyte donation from the time of informed consent until 30 days after the final study visit, and must agree to use effective contraception.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Event
Timeframe: Within 24 hours of administering the experimental drug
. Individuals with a history of definite drug or food allergy, or known allergic reaction to any component of this product;
. Known or suspected malignant tumors;
. History of unexplained syncope, symptomatic hypotension, or hypoglycemia;
. History or family history of long QT interval syndrome, or ECG showing QTcF \>= 450 ms in males or \>= 470 ms in females;
. History of chronic diarrhea, malabsorption, unexplained weight loss, or food intolerance;
. Individuals with a history of intracranial hemorrhage (e.g., after traffic accidents), stroke, or cerebrovascular disease;
. Any disease (e.g., acute gastritis, gastrointestinal ulcers, gastrointestinal bleeding, Henoch-Schönlein purpura, systemic lupus erythematosus, etc.) or medical history (e.g., coagulation disorders, history of intracranial hemorrhage, history of intraocular hemorrhage, history of hemophilia, history of von Willebrand disease, etc.) that, in the investigator's judgment, could alter or increase the tendency to bleed;
. Regular and continuous use within 3 months prior to screening of medications affecting coagulation function (e.g., clopidogrel, ticlopidine, dipyridamole, warfarin-like anticoagulants, novel oral anticoagulants such as rivaroxaban, apixaban, etc.), or prior treatment with anticoagulants such as heparin, low-molecular-weight heparin, or fibrinolytic agents;