Healthy ParticipantsPhase 1NCT07913048
A Study to Evaluate the PK/PD and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
A Phase 1 study testing KL0011034 injection in people with Healthy Participants, run by Hunan Kelun Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic characteristics of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants. To evaluate the pharmacodynamics and safety of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- KL0011034 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2026to 30 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Non-Elderly Trial Participants (Age≥ 18 years and <65 years)，Healthy Elderly Trial Participants（Age≥ 65 years ）;
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 28.0;
- From ICF signing to 3 months post-last dose: no conception plans (participant/partner), no sperm/egg donation, effective contraception for 3 months post-last dose; no unprotected sex within 2 weeks pre-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;
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- Physical examination, vital signs, 12-lead electrocardiogram, posterior-anterior chest radiograph, abdominal ultrasound examination, and abnormal laboratory test results；
- Elderly group: SBP ≥160 mmHg and/or DBP ≥100 mmHg; non-elderly group: SBP ≥140 mmHg and/or DBP ≥90 mmHg ；
- 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;
- 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-Dose Study to Evaluate the Pharmacokinetics/Pharmacodynamics and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
To evaluate the pharmacokinetic characteristics of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants.
To evaluate the pharmacodynamics and safety of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants.
Read the detailed description
This study is a single-center, non-randomized, open-label, parallel study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of a single dose of KL0011034 injection in healthy non-elderly and elderly trial participants.
The study plans to enroll 20 trial participants, who will be assigned to the elderly group and the non-elderly group, with 10 participants in each group. After signing the informed consent form, all trial participants will undergo screening from D-14 to D-2 according to the procedures specified in the protocol. Trial participants who successfully pass screening will be admitted to the study site on Day -1 (D-1) before dosing to complete the procedures specified in the protocol. On Day 1 (D1), all trial participants will receive a single intravenous infusion of the investigational drug (KL0011034 injection), and PK blood sampling, pharmacodynamic, and safety evaluations will be performed. After completing the corresponding laboratory tests and assessments on Day 2 (D2) and upon confirmation by the investigator, participants may be discharged from the study.
- Conditions
- Healthy Participants
- Being tested
- KL0011034 injection
- Keywords
- Healthy Participants
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
| Study group | Role | What they receive |
|---|---|---|
| Elderly group | Experimental | Ten elderly Trial Participants will receive KL0011034 injection Receives: Drug: KL0011034 injection |
| Non-Elderly group | Experimental | Ten non-elderly Trial Participants will receive KL0011034 injection; Receives: Drug: KL0011034 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter Cmax in plasma
Maximum peak plasma concentration (Cmax) of KL0011034 .
Measured: 24 hours post-dose for each period
PK parameter Tmax in plasma
Time of Cmax (Tmax) of KL0011034 .
Measured: 24 hours post-dose for each period
PK parameter AUC0-t in plasma
Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 .
Measured: 24 hours post-dose for each period
PK parameter AUC0-∞ in plasma
AUC from time zero to infinity (AUC0-∞) of KL0011034
Measured: 24 hours post-dose for each period
PK parameter t1/2 in plasma
Terminal-phase elimination half-life (t1/2) of KL0011034 .
Measured: 24 hours post-dose for each period
Secondary outcomes (5)
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 for each period
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 for each period
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: Day 1 for each period
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 for each period
Number of reported Adverse Events
Safety and tolerability was assessed by the number of volunteers with adverse events.
Measured: 24 hours post-dose for each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion24 Nov 2026 (estimated)
- Study completion30 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 ParticipantsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07913048
- Sponsor's protocol ID
- KL0011034-104
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Study to Evaluate the Pharmacokinetics/Pharmacodynamics and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
- ClinicalTrials.gov ID
- NCT07913048
- Acronym / sponsor ID
- KL0011034-104
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Nov 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 pharmacokinetic characteristics of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants.
To evaluate the pharmacodynamics and safety of a single intravenous injection of KL0011034 injection in healthy non-elderly and elderly trial participants.
Detailed description
This study is a single-center, non-randomized, open-label, parallel study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of a single dose of KL0011034 injection in healthy non-elderly and elderly trial participants.
The study plans to enroll 20 trial participants, who will be assigned to the elderly group and the non-elderly group, with 10 participants in each group. After signing the informed consent form, all trial participants will undergo screening from D-14 to D-2 according to the procedures specified in the protocol. Trial participants who successfully pass screening will be admitted to the study site on Day -1 (D-1) before dosing to complete the procedures specified in the protocol. On Day 1 (D1), all trial participants will receive a single intravenous infusion of the investigational drug (KL0011034 injection), and PK blood sampling, pharmacodynamic, and safety evaluations will be performed. After completing the corresponding laboratory tests and assessments on Day 2 (D2) and upon confirmation by the investigator, participants may be discharged from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly group | Experimental | Drug: KL0011034 injectionTen elderly Trial Participants will receive KL0011034 injection |
| Non-Elderly group | Experimental | Drug: KL0011034 injectionTen non-elderly Trial Participants will receive KL0011034 injection; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Non-Elderly Trial Participants (Age≥ 18 years and <65 years)，Healthy Elderly Trial Participants（Age≥ 65 years ）;
- Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 28.0;
- From ICF signing to 3 months post-last dose: no conception plans (participant/partner), no sperm/egg donation, effective contraception for 3 months post-last dose; no unprotected sex within 2 weeks pre-dose.;
Key exclusion criteria (23 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, single dose | Drug | Elderly group, Non-Elderly group |
Primary outcome
PK parameter Cmax in plasma
Time frame: 24 hours post-dose for each period
Maximum peak plasma concentration (Cmax) of KL0011034 .
PK parameter Tmax in plasma
Time frame: 24 hours post-dose for each period
Time of Cmax (Tmax) of KL0011034 .
PK parameter AUC0-t in plasma
Time frame: 24 hours post-dose for each period
Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 .
PK parameter AUC0-∞ in plasma
Time frame: 24 hours post-dose for each period
AUC from time zero to infinity (AUC0-∞) of KL0011034
PK parameter t1/2 in plasma
Time frame: 24 hours post-dose for each period
Terminal-phase elimination half-life (t1/2) of KL0011034 .
5 secondary outcomes
Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale
Time frame: Day 1 for each period
Electroencephalogram bispectrality index (BIS) monitoring
Time frame: Day 1 for each period
Loss of eyelash reflex
Time frame: Day 1 for each period
Modified Aldrete Scoring (Aldrete) Scale
Time frame: Day 1 for each period
Number of reported Adverse Events
Time frame: 24 hours post-dose for each period
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 3 Nov 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 in people with Healthy Participants, 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 3 inclusion and 23 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 3 Nov 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?
PK parameter Cmax in plasma (time frame: 24 hours post-dose for each period). The study lists 5 primary outcomes in all. 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 3 Nov 2026.