Healthy VolunteersPhase 1NCT07474545
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers
A Phase 1 study testing KL0011034 injection and Etomidate Injectable Emulsion in people with Healthy Volunteers, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers. 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 Etomidate Injectable Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 31 Dec 2027
- 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
- Able to understand the purpose, content, procedures, and possible risks of the trial,willing to participate and sign the informed consent;
- Volunteers aged 18-45 years (inclusive) at the time of signing the informed consent,no gender limit;
- The body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive);
- Agree not to conceive or father a child (and ensure their partners of childbearing potential do not conceive) and agree not to donate gametes from signing informed consent through 3 months after dosing; Agree to use effective contraception during this period;
- Able to communicate well with the investigator, and willing to comply with the protocol restrictions, and cooperate with the completion of the trial process.
Who cannot join
- The investigator considers that the volunteer has any current or past medical condition (including but not limited to disorders of the central nervous, cardiovascular, endocrine, respiratory, digestive, urinary, hematological, or lymphatic systems) that may interfere with the trial;
- History of anesthesia accident, serious adverse reaction to anesthesia or family history of anesthesia accident prior to screening;
- History of difficult mask ventilation, difficult intubation, or anticipated difficult airway management prior to screening, including but not limited to modified Mallampati score III-IV, bifid or absent uvula, micrognathia, or retrognathia；
- History of asthma, COPD, or obstructive sleep apnea; or current respiratory disease prior to screening;
- History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria prior to screening;
- Clinically significant abnormalities in physical examination, vital signs, chest X-ray, abdominal ultrasound, or clinical laboratory tests; or abnormal circadian rhythm of cortisol or ACTH deemed clinically significant by the investigator;
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- Clinically significant ECG abnormalities at screening, including QTcF≥ 450 ms (men) or ≥ 460 ms (female);
- Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody at screening;
- Pregnancy or lactation at screening; or positive pregnancy test for females of childbearing potential;
- Known history of drug or alcohol abuse or dependence within 12 months prior to screening, or positive urine drug test at screening;
- Alcohol abuse within 6 months prior to screening, positive breath alcohol test at screening, or unwillingness to abstain from alcohol during the trail;
- Positive urine cotinine test at screening, or history of regular smoking (≥5 cigarettes/day) within 6 months prior to screening, or unwillingness to abstain from tobacco use during the trial;
- Habitual consumption of >8 cups/day of tea, coffee, or other caffeinated beverages (1 cup ≈ 250 mL) prior to screening, or unwillingness to abstain from the above beverages during the trial;
- Use of any medications within the past 14 days, including prescription and over-the-counter medications, traditional Chinese medicine, health care products, and vitamins;
- Known allergy to etomidate or other anesthetics；or atopy (defined as allergy to ≥2 medications, foods, or pollen)；or prone to developing rashes or hives； or history of allergic diseases；or known allergy to the excipients or active pharmaceutical ingredients;
- Participation in any clinical trial within 3 months prior to screening, or failure to complete the follow-up period of a previous trial;
- Vaccination within 1 month (inactivated) or 3 months (live) prior to screening, or intent to receive any vaccine dinactivated/live/attenuated vaccine during the trial；
- Blood donation, or blood transfusion, or significant blood loss (>400 ml) within 3 months prior to screening; or planned blood donation or surgery during the trail or within 1 month after the trial;
- Surgery within 3 months prior to screening, ongoing post-surgical recovery, or planned surgical procedure during the trial;
- Difficulty in collecting blood, unable to tolerate venipuncture and/or having a history of haemorrhage or needle halo;
- Volunteers with unprotected sexual intercourse within 2 weeks before administration;
- Poor compliance,or any other circumstance deemed by the investigator to contraindicate participation.
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, 1 recruiting
- Recruiting
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, Placebo-Controlled,Positive-Controlled, Dose-Escalation, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of a Single Dose Injection of KL0011034 Injection in Healthy Chinese Volunteers
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.
Read the detailed description
This trial is a randomized, double-blind, placebo- and active-controlled, single-dose escalation study in healthy volunteers. A total of 76 volunteers will be enrolled. Healthy volunteers will be randomly assigned to receive KL0011034 injection, placebo, or Etomidate Injectable Emulsion. Each volunteer is allowed to participate in only one dose cohort; intra-volunteer dose escalation is not permitted. Enrollment into the next cohort will begin only after safety and tolerability data from the previous cohort have been reviewed and deemed acceptable by the investigator(s) and sponsor. If the highest dose is well tolerated, the investigator(s) and sponsor will evaluate the accumulated data and decide whether to terminate dose escalation or continue to higher dose levels.
- Conditions
- Healthy Volunteers
- Being tested
- KL0011034 injection, Placebo, Etomidate 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, single dose
PlaceboDrug
Intravenous injection, single dose
Etomidate Injectable EmulsionDrug
Intravenous injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| KL0011034 injection group | Experimental | Volunteers will receive KL0011034 injection in different doses. Receives: Drug: KL0011034 injection |
| KL0011034 injection placebo group | Placebo comparator | Volunteers will receive KL0011034 injection placebo. Receives: Drug: Placebo |
| Etomidate Injectable Emulsion group | Active comparator | Volunteers will receive Etomidate Injectable Emulsion. Receives: Drug: Etomidate 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: From first dose of drug until day 2
Secondary outcomes (9)
PK parameter Cmax in plasma
Maximum peak plasma concentration (Cmax) after single dose.
Measured: From first dose of drug until day 2
PK parameter Tmax in plasma
Time of Cmax (Tmax) after single dose. PK parameters will be assessed for plasma KL0011034 and its metabolite(s) .
Measured: From first dose of drug until day 2
PK parameter AUC0-t in plasma
Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose. PK parameters will be assessed for plasma KL0011034 and its metabolite(s) .
Measured: From first dose of drug until day 2
PK parameter AUC0-∞ in plasma
AUC from time zero to infinity (AUC0-∞) after single dose. PK parameters will be assessed for plasma KL0011034 and its metabolite(s) .
Measured: From first dose of drug until day 2
PK parameter t1/2 in plasma
Terminal-phase elimination half-life (t1/2) after single dose. PK parameters will be assessed for plasma KL0011034 and its metabolite(s) .
Measured: From first dose of drug until day 2
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: From first dose of drug until 10 minutes after fully alert on 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: From first dose of drug until 10 minutes after fully alert on day 1.
Loss of eyelash reflex
The eyelash reflex is a commonly used clinical method to assess the level of consciousness in patients. Gentle stimulation of the eyelashes with a cotton swab normally elicits a blink; absence of this response indicates loss of the eyelash reflex.
Measured: From first dose of drug until the reflex was fully restored on 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: From being fully alert until meeting the discharge criteria to leave the unit on day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start2 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- 76 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
- NCT07474545
- Sponsor's protocol ID
- KL0011034-101
- Status last verified
- May 2026
- First submitted
- 24 Feb 2026
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-Controlled,Positive-Controlled, Dose-Escalation, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of a Single Dose Injection of KL0011034 Injection in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT07474545
- Acronym / sponsor ID
- KL0011034-101
- Conditions
- Healthy Volunteers
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 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.
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.
Detailed description
This trial is a randomized, double-blind, placebo- and active-controlled, single-dose escalation study in healthy volunteers. A total of 76 volunteers will be enrolled. Healthy volunteers will be randomly assigned to receive KL0011034 injection, placebo, or Etomidate Injectable Emulsion. Each volunteer is allowed to participate in only one dose cohort; intra-volunteer dose escalation is not permitted. Enrollment into the next cohort will begin only after safety and tolerability data from the previous cohort have been reviewed and deemed acceptable by the investigator(s) and sponsor. If the highest dose is well tolerated, the investigator(s) and sponsor will evaluate the accumulated data and decide whether to terminate dose escalation or continue to higher dose levels.
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 |
|---|---|---|
| KL0011034 injection group | Experimental | Drug: KL0011034 injectionVolunteers will receive KL0011034 injection in different doses. |
| KL0011034 injection placebo group | Placebo comparator | Drug: PlaceboVolunteers will receive KL0011034 injection placebo. |
| Etomidate Injectable Emulsion group | Active comparator | Drug: Etomidate Injectable EmulsionVolunteers will receive Etomidate Injectable Emulsion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to understand the purpose, content, procedures, and possible risks of the trial,willing to participate and sign the informed consent;
- Volunteers aged 18-45 years (inclusive) at the time of signing the informed consent,no gender limit;
- The body weight: Male ≥ 50.0 kg, Female ≥ 45.0 kg; Body Mass Index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive);
- Agree not to conceive or father a child (and ensure their partners of childbearing potential do not conceive) and agree not to donate gametes from signing informed consent through 3 months after dosing; Agree to use effective contraception during this period;
- Able to communicate well with the investigator, and willing to comply with the protocol restrictions, and cooperate with the completion of the trial process.
Key exclusion criteria (22 listed)
- The investigator considers that the volunteer has any current or past medical condition (including but not limited to disorders of the central nervous, cardiovascular, endocrine, respiratory, digestive, urinary, hematological, or lymphatic systems) that may interfere with the trial;
- History of anesthesia accident, serious adverse reaction to anesthesia or family history of anesthesia accident prior to screening;
- History of difficult mask ventilation, difficult intubation, or anticipated difficult airway management prior to screening, including but not limited to modified Mallampati score III-IV, bifid or absent uvula, micrognathia, or retrognathia；
- History of asthma, COPD, or obstructive sleep apnea; or current respiratory disease prior to screening;
- History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria prior to screening;
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, single dose | Drug | KL0011034 injection group |
| PlaceboIntravenous injection, single dose | Drug | KL0011034 injection placebo group |
| Etomidate Injectable EmulsionIntravenous injection, single dose | Drug | Etomidate Injectable Emulsion group |
Primary outcome
Number of reported Adverse Events
Time frame: From first dose of drug until day 2
Safety and tolerability was assessed by the number of volunteers with adverse events.
9 secondary outcomes
PK parameter Cmax in plasma
Time frame: From first dose of drug until day 2
PK parameter Tmax in plasma
Time frame: From first dose of drug until day 2
PK parameter AUC0-t in plasma
Time frame: From first dose of drug until day 2
PK parameter AUC0-∞ in plasma
Time frame: From first dose of drug until day 2
PK parameter t1/2 in plasma
Time frame: From first dose of drug until day 2
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
Time frame: From first dose of drug until 10 minutes after fully alert on day 1.
Electroencephalogram bispectrality index (BIS) monitoring
Time frame: From first dose of drug until 10 minutes after fully alert on day 1.
Loss of eyelash reflex
Time frame: From first dose of drug until the reflex was fully restored on day 1.
Modified Aldrete Scoring (Aldrete) Scale
Time frame: From being fully alert until meeting the discharge criteria to leave the unit on 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 27 May 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 Etomidate 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: looking for participants now, as of the sponsor's last update on 27 May 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. Some participants in this study may receive a placebo. 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: From first dose of drug until day 2). 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 27 May 2026.