Trial · NCT07913048
A Study to Evaluate the PK/PD and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
NCT07913048, Phase 1, Not yet recruiting, Hunan Kelun Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the PK/PD and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants. Trials, record NCT07913048. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913048
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the PK/PD and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
- NCT number
- NCT07913048
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
- Conditions
- Healthy Participants
- Interventions
- KL0011034 injection
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PK parameter Cmax in plasma | 24 hours post-dose for each period | Maximum peak plasma concentration (Cmax) of KL0011034 . |
| Primary | PK parameter Tmax in plasma | 24 hours post-dose for each period | Time of Cmax (Tmax) of KL0011034 . |
| Primary | PK parameter AUC0-t in plasma | 24 hours post-dose for each period | Area under the concentration-time curve (AUC0-t) from time zero to time "t" of KL0011034 . |
| Primary | PK parameter AUC0-∞ in plasma | 24 hours post-dose for each period | AUC from time zero to infinity (AUC0-∞) of KL0011034 |
| Primary | PK parameter t1/2 in plasma | 24 hours post-dose for each period | Terminal-phase elimination half-life (t1/2) of KL0011034 . |
| Secondary | Modified Observer's Assessment of Alertness Sedation (MOAA/S) scale | Day 1 for each period | 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. |
| Secondary | Electroencephalogram bispectrality index (BIS) monitoring | Day 1 for each period | 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. |
| Secondary | Loss of eyelash reflex | Day 1 for each period | 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. |
| Secondary | Modified Aldrete Scoring (Aldrete) Scale | Day 1 for each period | 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. |
| Secondary | Number of reported Adverse Events | 24 hours post-dose for each period | Safety and tolerability was assessed by the number of volunteers with adverse events. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913048
GET https://conductscience.org/api/trials/v1/NCT07913048/registered