Postoperative AnalgesiaPhase 1NCT06681493
A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects
A Phase 1 study testing YZJ-4729 Tartrate injection and YZJ-4729 simulated injection in people with Postoperative Analgesia, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Part A Primary objective: To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection. Secondary objectives: To investigate the PK/PD profile of YZJ-4729 tartrate injection administered as a single dose; To investigate the metabolic transformation characteristics… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- YZJ-4729 Tartrate injection and YZJ-4729 simulated injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to 22 Sep 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects aged between 18 and 45 years (inclusive) on the day of signing the informed consent;
- Male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg. Body mass index within the range 19.0-26.0 kg/m 2 (inclusive);
- Subjects in good health without a history of serious diseases and chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system and mental system;
- From the date of signing the informed consent form until 6 months after the last dose of investigational drug, the subject (including partner) need to have no sperm or egg donation plan or pregnancy plan and voluntarily take effective contraceptive measures.
- Voluntarily need to sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.
Who cannot join
- Medical history of cardiovascular and respiratory system (such as sleep apnea syndrome, pulmonary heart disease or chronic bronchial asthma), liver, kidney, nervous system (such as epilepsy), blood system or mental disorders that the researcher considers clinically significant;
- Medical history of cardiovascular system disease, including but not limited to history or family history of syncope, coronary heart disease (such as coronary angiography diagnosis of coronary heart disease, history of acute coronary syndrome, history of myocardial infarction, etc.), valvular heart disease, heart failure, history of non-drug-induced bradyarrhythmia, frequent ventricular premature beats, ventricular tachycardia, etc.; or previous QTc prolongation or other risk factors for torsades de pointes (hypokalemia, etc.), or a family history of a first-degree relative (i.e., biological parent, brother, sister or child) with short QT syndrome, long QT syndrome, sudden death of unknown cause in his youth (less than/equal to 40 years old), drowning or sudden infant death syndrome;
- Medical history of symptomatic head trauma;
- History of frequent nausea or vomiting of any etiology;
- Medical history of glaucoma or any condition affecting pupil size;
- Major surgery or major trauma within 6 months prior to screening or planning to undergo surgery during the study;
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- Known to be allergic to two or more kinds of food and drugs;
- Known to be allergic to opioids, or have contraindications for the use of such drugs;
- Difficulties in collecting venous blood, or the cases with known needle and blood sickness history;
- Female subjects who are lactating, pregnant, preparing for pregnancy or have the abnormal pregnancy test results with clinical significance at screening;
- Clinically significant abnormal ECG findings at screening, such as QTcF ≥ 450 ms in men and QTcF ≥ 470 ms in women; PR interval ≥ 200 ms; QRS complex duration ≥ 120 ms;
- Abnormal vital signs at screening (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; respiratory < 16 breaths/min or > 20 breaths/min; pulse < 60 beats/min or >100 beats/min) or clinically significant abnormal physical examination, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), chest anteroposterior view or CT, abdominal color ultrasound (subject to the judgment of clinicians);
- Subjects having clinically significant abnormalities in any of hepatitis B virus surface antigen, Treponema pallidum-specific antibody, human immunodeficiency virus antibody and hepatitis C virus antibody at screening;
- Serum potassium, magnesium and calcium exceeding the upper limit of normal reference range or lower limit of normal reference range at screening;
- Oxygen saturation less than 95% at screening;
- History of any drug abuse within 1 year before screening or positive urine drug test results during screening;
- Regular drinkers within 6 months prior to screening (drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits 40% or 150 mL of wine) or breath alcohol test results > 0 mg/100 mL, or having taken any products containing alcohol within 48 hours prior to the first use of investigational drug or not agreeing to refrain from taking any products containing alcohol during the trial;
- Smoking more than 5 cigarettes a day within 3 months before screening, or using tobacco products within 48 hours before the first use of investigational drug, or not stopping using any tobacco products during the trial;
- Blood donation or massive blood loss (blood loss > 400 mL, excluding female menstrual blood loss), receiving blood transfusion or using blood products within 3 months before screening;
- Participation in any clinical trial within 3 months prior to screening;
- Attenuated/DNA nucleic acid/recombinant protein vaccination within 4 weeks prior to screening, or inactivated vaccination within 2 weeks prior to screening, or any planned vaccination during the trial;
- Any proposed combination of drugs that alter hepatic CYP2C9 and CYP3A4 enzyme activities, including potent inhibitors and inducers of enzymes that affect hepatic metabolism or that result in QT/QTc prolongation, 28 days prior to screening or during the trial;
- Subjects who have used or are using opioids within 14 days before the first use of investigational drug;
- Receiving other prescription or over-the-counter medications considered by the investigator to affect the results of this study evaluation within 14 days prior to the first dose of investigational drug;
- Consumption of grapefruit or grapefruit juice or any food or beverage containing grapefruit within 7 days before the first dose of investigational drug, or disagreement to refrain from consumption of such food or beverage during the trial;
- Taking or having taken any medication affecting pupil size within 48 hours prior to the first dose of investigational product;
- Taking any caffeine-rich food or beverage (coffee, tea, cola, chocolate, etc.) within 48 hours before the first dose of investigational product, or disagreeing to refrain from consuming them during the trial;
- Subjects who, in the opinion of the investigator, are not suitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and PK/PD of YZJ-4729 Tartrate Injection After A Single Ascending Dose
Part A
Primary objective:
Read more
- To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection.
Secondary objectives:
- To investigate the PK/PD profile of YZJ-4729 tartrate injection administered as a single dose;
- To investigate the metabolic transformation characteristics of YZJ-4729 tartrate;
- To assess the relationship between plasma concentrations and change in QT interval (C-QT) and the effect on QT interval in subjects after a single dose of YZJ-4729 tartrate injection.
Part B
Primary objective:
- To evaluate the safety, tolerability and pharmacokinetic profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates .
Secondary objectives:
- To investigate the PK/PD profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates.
- Conditions
- Postoperative Analgesia
- Being tested
- YZJ-4729 Tartrate injection, YZJ-4729 simulated injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YZJ-4729 Tartrate injectionDrug
Infusion, QD
YZJ-4729 simulated injectionDrug
Infusion, QD
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A Experimental: YZJ-4729 Tartrate injection; Part A Control: YZJ-4729 simulated injection Receives: Drug: YZJ-4729 Tartrate injection; Drug: YZJ-4729 simulated injection |
| Part B | Experimental | Subjects will receive YZJ-4729 Tartrate injection Receives: Drug: YZJ-4729 Tartrate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Incidence of participants with clinical laboratory abnormalities
Measured: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Incidence of participants with vital signs abnormalities
Measured: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Incidence of participants with physical exam abnormalities
Measured: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Cmax
Cmax is defined as the observed maximum plasma concentration.
Measured: Pre-dose to 72 hours post-dose
AUCinf
AUCinf is defined as the area under the plasma concentration-time curve extrapolated to infinity from time zero.
Measured: Pre-dose to 72 hours post-dose
AUC0-24h
AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to 24h.
Measured: Pre-dose to 72 hours post-dose
AUC0-t
AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to the last observable concentration.
Measured: Pre-dose to 72 hours post-dose
t1/2z
t1/2z is defined as the elimination half-life.
Measured: Pre-dose to 72 hours post-dose
Tmax
Tmax is defined as the observed time to reach Cmax.
Measured: Pre-dose to 72 hours post-dose
CL
CL is defined as the clearance.
Measured: Pre-dose to 72 hours post-dose
Vz
V is defined as the apparent volume of distribution.
Measured: Pre-dose to 72 hours post-dose
MRT
MRT is defined as the mean residence time.
Measured: Pre-dose to 72 hours post-dose
Ae0-t
Ae0-t is defined as the cumulative amount of drug excreted in urine or fecal from time zero to the last observable concentration.
Measured: Pre-dose to 72 hours post-dose
Cumulative excretion percentage of drug through urine and feces
Measured: Pre-dose to 72 hours post-dose
Secondary outcomes (2)
Pupil diameter
Measured: Pre-dose to 12 hours post-dose
Change from baseline of QTcF by timepoint
Measured: Pre-dose to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start12 Oct 2022
- Primary completion14 Apr 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681493
- Sponsor's protocol ID
- YZJ-4729-1-01
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and PK/PD of YZJ-4729 Tartrate Injection After A Single Ascending Dose
- ClinicalTrials.gov ID
- NCT06681493
- Acronym / sponsor ID
- YZJ-4729-1-01
- Conditions
- Postoperative Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 8 Nov 2024 (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.
Part A
Primary objective:
- To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection.
Secondary objectives:
- To investigate the PK/PD profile of YZJ-4729 tartrate injection administered as a single dose;
- To investigate the metabolic transformation characteristics of YZJ-4729 tartrate;
- To assess the relationship between plasma concentrations and change in QT interval (C-QT) and the effect on QT interval in subjects after a single dose of YZJ-4729 tartrate injection.
Part B
Primary objective:
- To evaluate the safety, tolerability and pharmacokinetic profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates .
Secondary objectives:
- To investigate the PK/PD profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: YZJ-4729 Tartrate injection, Drug: YZJ-4729 simulated injectionPart A Experimental: YZJ-4729 Tartrate injection; Part A Control: YZJ-4729 simulated injection |
| Part B | Experimental | Drug: YZJ-4729 Tartrate injectionSubjects will receive YZJ-4729 Tartrate injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects aged between 18 and 45 years (inclusive) on the day of signing the informed consent;
- Male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg. Body mass index within the range 19.0-26.0 kg/m 2 (inclusive);
- Subjects in good health without a history of serious diseases and chronic diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system and mental system;
- From the date of signing the informed consent form until 6 months after the last dose of investigational drug, the subject (including partner) need to have no sperm or egg donation plan or pregnancy plan and voluntarily take effective contraceptive measures.
- Voluntarily need to sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.
Key exclusion criteria (28 listed)
- Medical history of cardiovascular and respiratory system (such as sleep apnea syndrome, pulmonary heart disease or chronic bronchial asthma), liver, kidney, nervous system (such as epilepsy), blood system or mental disorders that the researcher considers clinically significant;
- Medical history of cardiovascular system disease, including but not limited to history or family history of syncope, coronary heart disease (such as coronary angiography diagnosis of coronary heart disease, history of acute coronary syndrome, history of myocardial infarction, etc.), valvular heart disease, heart failure, history of non-drug-induced bradyarrhythmia, frequent ventricular premature beats, ventricular tachycardia, etc.; or previous QTc prolongation or other risk factors for torsades de pointes (hypokalemia, etc.), or a family history of a first-degree relative (i.e., biological parent, brother, sister or child) with short QT syndrome, long QT syndrome, sudden death of unknown cause in his youth (less than/equal to 40 years old), drowning or sudden infant death syndrome;
- Medical history of symptomatic head trauma;
- History of frequent nausea or vomiting of any etiology;
- Medical history of glaucoma or any condition affecting pupil size;
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 |
|---|---|---|
| YZJ-4729 Tartrate injectionInfusion, QD | Drug | Part A, Part B |
| YZJ-4729 simulated injectionInfusion, QD | Drug | Part A |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Incidence of participants with clinical laboratory abnormalities
Time frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Incidence of participants with vital signs abnormalities
Time frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Incidence of participants with physical exam abnormalities
Time frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17
Cmax
Time frame: Pre-dose to 72 hours post-dose
Cmax is defined as the observed maximum plasma concentration.
AUCinf
Time frame: Pre-dose to 72 hours post-dose
AUCinf is defined as the area under the plasma concentration-time curve extrapolated to infinity from time zero.
AUC0-24h
Time frame: Pre-dose to 72 hours post-dose
AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to 24h.
AUC0-t
Time frame: Pre-dose to 72 hours post-dose
AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to the last observable concentration.
t1/2z
Time frame: Pre-dose to 72 hours post-dose
t1/2z is defined as the elimination half-life.
Tmax
Time frame: Pre-dose to 72 hours post-dose
Tmax is defined as the observed time to reach Cmax.
CL
Time frame: Pre-dose to 72 hours post-dose
CL is defined as the clearance.
Vz
Time frame: Pre-dose to 72 hours post-dose
V is defined as the apparent volume of distribution.
MRT
Time frame: Pre-dose to 72 hours post-dose
MRT is defined as the mean residence time.
Ae0-t
Time frame: Pre-dose to 72 hours post-dose
Ae0-t is defined as the cumulative amount of drug excreted in urine or fecal from time zero to the last observable concentration.
Cumulative excretion percentage of drug through urine and feces
Time frame: Pre-dose to 72 hours post-dose
2 secondary outcomes
Pupil diameter
Time frame: Pre-dose to 12 hours post-dose
Change from baseline of QTcF by timepoint
Time frame: Pre-dose to 24 hours post-dose
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 30 Jun 2026.
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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. 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 testing YZJ-4729 Tartrate injection and YZJ-4729 simulated injection in people with Postoperative Analgesia, run by Shanghai Haiyan 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 5 inclusion and 28 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 30 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?
Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Part A： From Day 1 to Day 5 Part B： From Day 1 to Day 17). The study lists 15 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 30 Jun 2026.