Healthy VolunteersPhase 1NCT07828470
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
A Phase 1 study testing KL0011034 injection and propofol injectable emulsion in people with Healthy Volunteers, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for durations of 1 hour, 2 hours, and 3 hours, and evaluating the pharmacokinetic of the… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- KL0011034 injection and propofol injectable emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2026to 13 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2;
- There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;
- Agreed to use contraception for 3 months post-dose.
Who cannot join
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
- Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
- History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
- History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
Show all 22Show fewer
- History of any surgery within 3 months;
- History of any Medication within 14 days;
- History of any clinical study within 3 months;
- History of any vaccine within 1 month;
- History of any drug abuse;
- Needle sickness, Hematosickness;
- Massive blood loss (> 400 mL) in the past 3 months;
- Female volunteers are pregnant or lactating;
- History of unprotected sex within 2 weeks;
- Heavy smoker ( more than 5 cigarettes/day) within 3 months;
- History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
- Heavy caffeine intake;
- History of grapefruit, xanthine-rich foods intake within 48 hours;
- Positive alcohol test;
- Positive nicotine test;
- Positive drugs of abuse test result.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third XIANGYA Hospital of Central South University
Changsha, Hunan, 410205
Guoping Yang, 13974817168, ygp9880@163.com
Saiying Wang, 0731-88618150, 1771303488@qq.com
About this study
Official title: A Single-center, Randomized, Double-blind, Propofol Position-controlled Phase I Clinical Study Evaluating the Safety, Pharmacokinetics/Pharmacodynamics of KL0011034 Injection by Continuous Infusion in Healthy Chinese Adult Subjects
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for durations of 1 hour, 2 hours, and 3 hours, and evaluating the pharmacokinetic of the KL0011034 injection.
Read the detailed description
This study is a randomized, double-blind, active-controlled, continuous-infusion trial. It is planned to enroll 30 healthy subjects, who will be divided into three continuous-infusion groups (Groups 1 to 3), with 10 subjects per group. Block randomization will be used to assign subjects in a 4:1 ratio to either the test drug group or the active control group. In the test drug group, subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection during the anesthesia maintenance phase. In the active control group, subjects will receive propofol injectable emulsion 2 mg/kg during induction and propofol emulsion injection during maintenance. The maintenance durations for Groups 1, 2, and 3 are 1 hour (+5 min), 2 hours (+5 min), and 3 hours (+5 min), respectively. During the study, subjects will undergo assessments of safety, tolerability, and pharmacodynamics, and blood samples will be collected for pharmacokinetic analysis.
- Conditions
- Healthy Volunteers
- Being tested
- KL0011034 injection, propofol injectable emulsion
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL0011034 injectionDrug
Intravenous injection, continuous infusion
propofol injectable emulsionDrug
Intravenous injection, continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for low-dose group is 1 hour (+5 min). Receives: Drug: KL0011034 injection; Drug: propofol injectable emulsion |
| Medium-dose group | Experimental | subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for medium-dose group is 2 hours (+5 min). Receives: Drug: KL0011034 injection; Drug: propofol injectable emulsion |
| High-dose group | Experimental | subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for high-dose group is 3 hours (+5 min). Receives: Drug: KL0011034 injection; Drug: propofol injectable emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of reported Adverse Events
Safety and tolerability was assessed by the number of volunteers with adverse events.
Measured: 24 hours post-dose
Secondary outcomes (12)
PK parameter Cmax in plasma
Maximum peak plasma concentration (Cmax) of KL0011034 and its metabolite
Measured: 24 hours post-dose
PK parameter Tmax in plasma
Time of Cmax (Tmax) of KL0011034 and its metabolite
Measured: 24 hours post-dose
PK parameter AUC0-t in plasma
Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 and its metabolite
Measured: 24 hours post-dose
PK parameter AUC0-∞ in plasma
AUC from time zero to infinity (AUC0-∞) of KL0011034 and its metabolite
Measured: 24 hours post-dose
PK parameter t1/2 in plasma
Terminal-phase elimination half-life (t1/2) of KL0011034 and its metabolite
Measured: 24 hours post-dose
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
MOAA/S is a commonly used clinical sedation assessment scale, ranging from 0 to 5, which helps clinicians determine the level of sedation in patients. A score of 5 indicates full consciousness, whereas a score of 0 indicates deep coma. Lower scores correspond to deeper levels of sedation.
Measured: Day 1
Electroencephalogram bispectrality index (BIS) monitoring
BIS is the most widely used method for the continuous monitoring of sedation depth in clinical anesthesia. BIS values range from 0 to 100, where 100 represents complete wakefulness and 0 indicates complete cortical electrical inhibition.
Measured: Day 1
Modified Aldrete Scoring (Aldrete) Scale
The Modified Aldrete Score is the most widely used standardized tool for assessing discharge readiness from post-anesthesia care unit (PACU). It evaluates five parameters: activity, respiration, blood pressure consciousness, and SpO₂. Ranging from 0 to 10, the higher the score, the better the quality of recovery.
Measured: Day 1
Post-Anesthetic Discharge Scoring System
PADSS assesses based on five dimensions: vital signs, activity status, nausea and vomiting, pain severity, and surgical bleeding. Each item is scored from 0 to 2, with a total score of 10, the higher the score, the better the quality of recovery. Discharge can be arranged when the score reaches 9.
Measured: Day 1
The time of complete awakening
The definition of complete awakening is that the MOAA/S score is 5 for three consecutive times. The time point when the first score among the three consecutive times is 5 is the time point of complete awakening.
Measured: Day 1
Mini-Mental State Examination
The quality of awakening was evaluated through the "orientation in the recovery period" and "memory" sections of the MMSE scale. The "orientation in the recovery period" assesses based on 10 questions, each question is scored from 0 to 1, with a total score of 10. The "memory" assesses based on 3 questions, including the repetition of 6 different things and performing 5 subtraction calculations, with a total score of 11. the higher the score, the better the quality of awakening.
Measured: Day 1
Anesthesia satisfaction
satisfaction of anesthesiologists and satisfaction of patients. The "satisfaction of patients" assesses based on 2 parts, with a total score of 150. the higher the score, the better the quality of recovery. Part A: How do you feeling in the past 24 hours ( including 10 questions, each question is scored from 0 to 10, with a total score of 100 ). Part B: Have you experienced following 5 situations in the past 24 hours ( each situation is scored from 0 to 10, with a total score of 50 ).
The " satisfaction of anesthesiologists" assesses based on 2 dimensions: Maintaining hemodynamic stability during the maintenance period, and Awakening status (whether agitated, choking, or coughing). Each item is scored from 1 to 5, with a total score of 10, the higher the score, the better the quality of recovery.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start13 Oct 2026 (estimated)
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828470
- Sponsor's protocol ID
- KL0011034-103
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Propofol Position-controlled Phase I Clinical Study Evaluating the Safety, Pharmacokinetics/Pharmacodynamics of KL0011034 Injection by Continuous Infusion in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT07828470
- Acronym / sponsor ID
- KL0011034-103
- Conditions
- Healthy Volunteers
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 18 Sep 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.
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for durations of 1 hour, 2 hours, and 3 hours, and evaluating the pharmacokinetic of the KL0011034 injection.
Detailed description
This study is a randomized, double-blind, active-controlled, continuous-infusion trial. It is planned to enroll 30 healthy subjects, who will be divided into three continuous-infusion groups (Groups 1 to 3), with 10 subjects per group. Block randomization will be used to assign subjects in a 4:1 ratio to either the test drug group or the active control group. In the test drug group, subjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection during the anesthesia maintenance phase. In the active control group, subjects will receive propofol injectable emulsion 2 mg/kg during induction and propofol emulsion injection during maintenance. The maintenance durations for Groups 1, 2, and 3 are 1 hour (+5 min), 2 hours (+5 min), and 3 hours (+5 min), respectively. During the study, subjects will undergo assessments of safety, tolerability, and pharmacodynamics, and blood samples will be collected for pharmacokinetic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: KL0011034 injection, Drug: propofol injectable emulsionsubjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for low-dose group is 1 hour (+5 min). |
| Medium-dose group | Experimental | Drug: KL0011034 injection, Drug: propofol injectable emulsionsubjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for medium-dose group is 2 hours (+5 min). |
| High-dose group | Experimental | Drug: KL0011034 injection, Drug: propofol injectable emulsionsubjects will receive propofol injectable emulsion 2 mg/kg during the anesthesia induction phase, followed by KL0011034 injection or propofol injectable emulsion during the anesthesia maintenance phase. The maintenance durations for high-dose group is 3 hours (+5 min). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign the informed consent form
- Health participants (Age: 18~45 years);
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19 ≤BMI≤ 26.0kg/m2;
- There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests;
- Agreed to use contraception for 3 months post-dose.
Key exclusion criteria (22 listed)
- Allergy or Drug hypersensitivity;
- Clinically significant Medical History;
- History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
- Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
- History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
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 |
|---|---|---|
| KL0011034 injectionIntravenous injection, continuous infusion | Drug | High-dose group, Low-dose group, Medium-dose group |
| propofol injectable emulsionIntravenous injection, continuous infusion | Drug | High-dose group, Low-dose group, Medium-dose group |
Primary outcome
Number of reported Adverse Events
Time frame: 24 hours post-dose
Safety and tolerability was assessed by the number of volunteers with adverse events.
12 secondary outcomes
PK parameter Cmax in plasma
Time frame: 24 hours post-dose
PK parameter Tmax in plasma
Time frame: 24 hours post-dose
PK parameter AUC0-t in plasma
Time frame: 24 hours post-dose
PK parameter AUC0-∞ in plasma
Time frame: 24 hours post-dose
PK parameter t1/2 in plasma
Time frame: 24 hours post-dose
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
Time frame: Day 1
Electroencephalogram bispectrality index (BIS) monitoring
Time frame: Day 1
Modified Aldrete Scoring (Aldrete) Scale
Time frame: Day 1
Post-Anesthetic Discharge Scoring System
Time frame: Day 1
The time of complete awakening
Time frame: Day 1
Mini-Mental State Examination
Time frame: Day 1
Anesthesia satisfaction
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 KL0011034 injection and propofol injectable emulsion in people with Healthy Volunteers, run by Hunan Kelun Pharmaceutical 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 22 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: opening soon, as of the sponsor's last update on 18 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Qi (028-82339360, qiw@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reported Adverse Events (time frame: 24 hours post-dose). 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 18 Sep 2026.