Clinical Trials in China / NCT07913048
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Phase 1
A Study to Evaluate the PK/PD and Safety of KL0011034 Injection in Healthy Non-Elderly and Elderly Trial Participants
NCT07913048 · tracked via the Priya Life Science China tracker
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
KL0011034 injection: Intravenous injection, single dose
Study 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.
Eligibility
Inclusion Criteria:
1. Healthy Non-Elderly Trial Participants (Age≥ 18 years and \<65 years)，Healthy Elderly Trial Participants（Age≥ 65 years ）;
2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 28.0;
3. 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.;
Exclusion Criteria:
1. Allergy or Drug hypersensitivity;
2. Clinically significant Medical History;
3. History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia;
4. Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation;
5. History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome;
6. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria;
7. Physical examination, vital signs, 12-lead electrocardiogram, posterior-anterior chest radiograph, abdominal ultrasound examination, and abnormal laboratory test results；
8. Elderly group: SBP ≥160 mmHg and/or DBP ≥100 mmHg; non-elderly group: SBP ≥140 mmHg and/or DBP ≥90 mmHg ；
9. History of any surgery within 3 months;
10. History of any Medication within 14 days;
11. History of any clinical study within 3 months;
12. History of any vaccine within 1 month;
13. History of any drug abuse;
14. Needle sickness, Hematosickness;
15. Massive blood loss (\> 400 mL) in the past 3 months;
16. Female volunteers are pregnant or lactating;
17. Heavy smoker ( more than 5 cigarettes/day) within 3 months;
18. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
19. Heavy caffeine intake;
20. History of grapefruit, xanthine-rich foods intake within 48 hours;
21. Positive alcohol test;
22. Positive nicotine test;
23. Positive drugs of abuse test result.
Primary outcome measure(s)
- PK parameter Cmax in plasma — 24 hours post-dose for each period
Maximum peak plasma concentration (Cmax) of KL0011034 . - PK parameter Tmax in plasma — 24 hours post-dose for each period
Time of Cmax (Tmax) of KL0011034 . - 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 . - PK parameter AUC0-∞ in plasma — 24 hours post-dose for each period
AUC from time zero to infinity (AUC0-∞) of KL0011034 - PK parameter t1/2 in plasma — 24 hours post-dose for each period
Terminal-phase elimination half-life (t1/2) of KL0011034 .
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Third XIANGYA Hospital of Central South University | Changsha | Hunan |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07913048 on ClinicalTrials.gov ↗ ← All trials in China