Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research ParticipantsPhase 1ZKLJ02-INCT07638098
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZKLJ02 Injection in Healthy Chinese Research Participants
A Phase 1 study of Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants, run by Yunnan Zhongke Longjin Biotechnology Co.,Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 18 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Presence of significant factors affecting normal venipuncture, such as history of heparin allergy, history of heparin-induced thrombocytopenia, inability to tolerate venipuncture, or history of needle or blood phobia;
- Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis antibody;
- Blood donation or blood loss of more than 500 mL within 3 months prior to screening;
- Participation in any other drug or medical device clinical trial within 3 months prior to screening, or currently participating in another clinical trial, or still within five half-lives of an investigational medicinal product at the time of screening;
- Use of any prescription medication, over-the-counter drug, or dietary supplement within 14 days or five half-lives (whichever is longer) prior to the first administration of the study drug;
- Hospitalization or major surgery within 6 months prior to screening;
- History of drug abuse within 9 months prior to screening;
- Individuals with a history of alcoholism or regular alcohol consumption within 9 months prior to screening, defined as more than 14 alcohol units per week (14 units = 8 bottles of beer (500 mL each, 3.5% alcohol content) or 500 g of baijiu (45% alcohol content) or 1.5 bottles of wine (750 mL each, 13% alcohol content)), or those unwilling to abstain from alcohol during the study period;
- Study participants who smoked more than 5 cigarettes per day in the past 6 months, or used tobacco-containing alternative products in equivalent amounts, or who cannot ensure complete abstinence from smoking during the study period;
- Pregnant or lactating women, those with a positive pregnancy test result, and female study participants who engaged in unprotected sexual activity within 2 weeks prior to the start of screening;
- Onset of acute illness during the screening phase or prior to the first administration of study medication;
- Consumption within 48 hours before dosing of any food or beverage containing caffeine, alcohol, xanthine, or grapefruit components (e.g., coffee, strong tea, chocolate, etc.);
- Positive breath alcohol test result or positive drug abuse screening result;
- Any individual with special dietary requirements who cannot comply with the standardized diet (e.g., intolerance to standard meals, lactose intolerance, etc.);
- Other conditions deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants
- Being tested
- 10 mg of ZKLJ02 for injection or placebo, 20 mg of ZKLJ02 for injection or placebo, 40 mg of ZKLJ02 for injection or placebo, 80 mg of ZKLJ02 for injection or placebo, 120 mg of ZKLJ02 for injection or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg of ZKLJ02 for injection or placeboDrug
Dissolve 10 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.
20 mg of ZKLJ02 for injection or placeboDrug
Dissolve 20 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.
40 mg of ZKLJ02 for injection or placeboDrug
Dissolve 40 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.
80 mg of ZKLJ02 for injection or placeboDrug
Dissolve 80 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.
120 mg of ZKLJ02 for injection or placeboDrug
Dissolve 120 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2.
| Study group | Role | What they receive |
|---|---|---|
| Dose Group 1 | Experimental | Not described Receives: Drug: 10 mg of ZKLJ02 for injection or placebo |
| Dose Group 2 | Experimental | Not described Receives: Drug: 20 mg of ZKLJ02 for injection or placebo |
| Dose Group 3 | Experimental | Not described Receives: Drug: 40 mg of ZKLJ02 for injection or placebo |
| Dose Group 4 | Experimental | Not described Receives: Drug: 80 mg of ZKLJ02 for injection or placebo |
| Dose Group 5 | Experimental | Not described Receives: Drug: 120 mg of ZKLJ02 for injection or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
The incidence rate of adverse events, severity and nature of adverse events, correlation between adverse events and investigational products
Measured: Within 24 hours of administering the experimental drug
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax)
Measured: Within 8 hours of administering the experimental drug
Area Under the Plasma Concentration Time Curve (AUC)
Measured: Within 8 hours of administering the experimental drug
Time to the Maximum Plasma Concentration (Tmax)
Measured: Within 8 hours of administering the experimental drug
Activated Partial Thromboplastin Time (APTT)
Measured: Within 24 hours of administering the experimental drug
Prothrombin Time (PT)
Measured: Within 24 hours of administering the experimental drug
Thrombin Time (TT)
Measured: Within 24 hours of administering the experimental drug
Incidence rate of antidrug antibody (ADA)
Measured: Within 7 days of administering the experimental drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start11 Aug 2025
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yunnan Zhongke Longjin Biotechnology Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638098
- Sponsor's protocol ID
- YunnanZhongkeLongjinBio
- Other IDs
- ChiCTR2500111786
- Acronym
- ZKLJ02-I
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07638098
- Acronym / sponsor ID
- ZKLJ02-I / YunnanZhongkeLongjinBio
- Conditions
- Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yunnan Zhongke Longjin Biotechnology Co.,Ltd.University, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 10 Jun 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 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Group 1 | Experimental | Drug: 10 mg of ZKLJ02 for injection or placebo |
| Dose Group 2 | Experimental | Drug: 20 mg of ZKLJ02 for injection or placebo |
| Dose Group 3 | Experimental | Drug: 40 mg of ZKLJ02 for injection or placebo |
| Dose Group 4 | Experimental | Drug: 80 mg of ZKLJ02 for injection or placebo |
| Dose Group 5 | Experimental | Drug: 120 mg of ZKLJ02 for injection or placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
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 |
|---|---|---|
| 10 mg of ZKLJ02 for injection or placeboDissolve 10 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2. | Drug | Dose Group 1 |
| 20 mg of ZKLJ02 for injection or placeboDissolve 20 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2. | Drug | Dose Group 2 |
| 40 mg of ZKLJ02 for injection or placeboDissolve 40 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2. | Drug | Dose Group 3 |
| 80 mg of ZKLJ02 for injection or placeboDissolve 80 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2. | Drug | Dose Group 4 |
| 120 mg of ZKLJ02 for injection or placeboDissolve 120 mg of ZKLJ02 for injection or placebo in 250 ml of 0.9% sodium chloride injection and administer intravenously over 2 hours ± 10 minutes within 1 hour before medication; the ratio of study participants receiving ZKLJ02 for injection to placebo is 8:2. | Drug | Dose Group 5 |
Primary outcome
Adverse Event
Time frame: Within 24 hours of administering the experimental drug
The incidence rate of adverse events, severity and nature of adverse events, correlation between adverse events and investigational products
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Within 8 hours of administering the experimental drug
Area Under the Plasma Concentration Time Curve (AUC)
Time frame: Within 8 hours of administering the experimental drug
Time to the Maximum Plasma Concentration (Tmax)
Time frame: Within 8 hours of administering the experimental drug
Activated Partial Thromboplastin Time (APTT)
Time frame: Within 24 hours of administering the experimental drug
Prothrombin Time (PT)
Time frame: Within 24 hours of administering the experimental drug
Thrombin Time (TT)
Time frame: Within 24 hours of administering the experimental drug
Incidence rate of antidrug antibody (ADA)
Time frame: Within 7 days of administering the experimental drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 of Evaluate the Safety and Tolerability of ZKLJ02 Injection in Healthy Chinese Research Participants, run by Yunnan Zhongke Longjin Biotechnology 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 6 inclusion and 23 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: finished, as of the sponsor's last update on 10 Jun 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Within 24 hours of administering the experimental drug). 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 10 Jun 2026.