A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: KL0011034 injection; Drug: Placebo; Drug: Etomidate Injectable Emulsion

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 Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Qi; Phone Number: 028-82339360; Email: qiw@kelun.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410205
      • Recruiting
      • The third xiangya hospital of Central South University
      • Contact: Guoping Yang; Phone Number: 13974817168; Email: ygp9880@163.com
      • Contact: Saiying Wang; Phone Number: 0731-88618150; Email: 1771303488@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able to understand the purpose, content, procedures, and possible risks of the trial,willing to participate and sign the informed consent;
2. Volunteers aged 18-45 years (inclusive) at the time of signing the informed consent,no gender limit;
3. 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);
4. 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;
5. Able to communicate well with the investigator, and willing to comply with the protocol restrictions, and cooperate with the completion of the trial process.

Exclusion Criteria:

1. 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;
2. History of anesthesia accident, serious adverse reaction to anesthesia or family history of anesthesia accident prior to screening;
3. 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；
4. History of asthma, COPD, or obstructive sleep apnea; or current respiratory disease prior to screening;
5. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria prior to screening;
6. 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;
7. Clinically significant ECG abnormalities at screening, including QTcF≥ 450 ms (men) or ≥ 460 ms (female);
8. Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody at screening;
9. Pregnancy or lactation at screening; or positive pregnancy test for females of childbearing potential;
10. Known history of drug or alcohol abuse or dependence within 12 months prior to screening, or positive urine drug test at screening;
11. Alcohol abuse within 6 months prior to screening, positive breath alcohol test at screening, or unwillingness to abstain from alcohol during the trail;
12. 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;
13. 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;
14. Use of any medications within the past 14 days, including prescription and over-the-counter medications, traditional Chinese medicine, health care products, and vitamins;
15. 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;
16. Participation in any clinical trial within 3 months prior to screening, or failure to complete the follow-up period of a previous trial;
17. 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；
18. 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;
19. Surgery within 3 months prior to screening, ongoing post-surgical recovery, or planned surgical procedure during the trial;
20. Difficulty in collecting blood, unable to tolerate venipuncture and/or having a history of haemorrhage or needle halo;
21. Volunteers with unprotected sexual intercourse within 2 weeks before administration;
22. Poor compliance,or any other circumstance deemed by the investigator to contraindicate participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KL0011034 injection group; Volunteers will receive KL0011034 injection in different doses.	Drug: KL0011034 injection; Intravenous injection, single dose
Placebo Comparator: KL0011034 injection placebo group; Volunteers will receive KL0011034 injection placebo.	Drug: Placebo; Intravenous injection, single dose
Active Comparator: Etomidate Injectable Emulsion group; Volunteers will receive Etomidate Injectable Emulsion.	Drug: Etomidate Injectable Emulsion; Intravenous injection, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported Adverse Events	Safety and tolerability was assessed by the number of volunteers with adverse events.	From first dose of drug until day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter Cmax in plasma	Maximum peak plasma concentration (Cmax) after single dose.	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) .	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) .	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) .	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) .	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.	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.	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.	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.	From being fully alert until meeting the discharge criteria to leave the unit on day 1.

Collaborators and Investigators

• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: KL0011034-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No