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

NCT07474545 | Not Yet Recruiting Phase 1

• 1 other identifier: KL0011034-101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.

Conditions

Healthy Volunteers

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• PK parameter Cmax in plasma

  From first dose of drug until day 2

• PK parameter Tmax in plasma

  From first dose of drug until day 2

• PK parameter AUC0-t in plasma

  From first dose of drug until day 2

• PK parameter AUC0-∞ in plasma

  From first dose of drug until day 2

• PK parameter t1/2 in plasma

  From first dose of drug until day 2

Study Arms (3)

KL0011034 injection group

EXPERIMENTAL

Volunteers will receive KL0011034 injection in different doses.

Drug: KL0011034 injection

KL0011034 injection placebo group

PLACEBO COMPARATOR

Volunteers will receive KL0011034 injection placebo.

Drug: Placebo

Etomidate Injectable Emulsion group

ACTIVE COMPARATOR

Volunteers will receive Etomidate Injectable Emulsion.

Drug: Etomidate Injectable Emulsion

Interventions

KL0011034 injection DRUG

Intravenous injection, single dose

KL0011034 injection group

Placebo DRUG

Intravenous injection, single dose

KL0011034 injection placebo group

Etomidate Injectable Emulsion DRUG

Intravenous injection, single dose

Etomidate Injectable Emulsion group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Hunan Kelun Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third XIANGYA Hospital of Central South University

Changsha, Hunan, 410205, China

Location

Central Study Contacts

Wei Qi

CONTACT

028-82339360; qiw@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 16, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)