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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Wei Qi
- Phone Number: 028-82339360
- Email: qiw@kelun.com
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: KL0011034 injection group
Volunteers will receive KL0011034 injection in different doses.
|
Intravenous injection, single dose
|
|
Placebo Comparator: KL0011034 injection placebo group
Volunteers will receive KL0011034 injection placebo.
|
Intravenous injection, single dose
|
|
Active Comparator: Etomidate Injectable Emulsion group
Volunteers will receive Etomidate Injectable Emulsion.
|
Intravenous injection, single dose
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From first dose of drug until day 2
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PK parameter Cmax in plasma
Time Frame: From first dose of drug until day 2
|
Maximum peak plasma concentration (Cmax) after single dose.
|
From first dose of drug until day 2
|
|
PK parameter Tmax in plasma
Time Frame: From first dose of drug until day 2
|
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
Time Frame: From first dose of drug until day 2
|
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
Time Frame: From first dose of drug until day 2
|
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
Time Frame: From first dose of drug until day 2
|
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
Time Frame: From first dose of drug until 10 minutes after fully alert on day 1.
|
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
Time Frame: From first dose of drug until 10 minutes after fully alert on day 1.
|
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
Time Frame: From first dose of drug until the reflex was fully restored on day 1.
|
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
Time Frame: From being fully alert until meeting the discharge criteria to leave the unit on day 1.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- KL0011034-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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