Healthy Participants
Conditions
Keywords
Healthy
Brief summary
The purpose of this study is to evaluate the safety,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
Interventions
DRUGKLA318-2 Nanocrystal Injection
Intravenous injection, single dose
DRUGCelebrex Capsule
P.O., single dose
Sponsors
Hunan Kelun Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Health participants (Age: 18\~45 years); 2. Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0; 3. Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
Exclusion criteria
1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. Gastrointestinal ulcers or gastrointestinal bleeding; 4. History of any surgery within 4 weeks; 5. History of any Medication within 14 days; 6. History of any drug interactions with celecoxib within 30 days; 7. History of any clinical study within 3 months; 8. History of any vaccine within 1 month; 9. History of any drug abuse, or positive drugs of abuse test result; 10. Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia; 11. Massive blood loss (\> 200 mL) in the past 3 months; 12. Special requirements for diet; 13. Heavy smoker ( more than 3 cigarettes/day) within 3 months; 14. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months, or positive alcohol test; 15. Heavy caffeine intake; 16. History of grapefruit, xanthine-rich foods intake within 7 days; 17. Female participants are pregnant or lactating; 18. History of unprotected sex within 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) | UP to Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter Cmax | UP to Day 3 | Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses |
| PK parameter Tmax | UP to Day 3 | Time of Cmax (Tmax) after single dose and in a steady state after multiple doses |
| PK parameter AUC0-t | UP to Day 3 | Area under the concentration-time curve (AUC0-t) from time zero to time "t" after single dose and in a steady state after multiple doses |
| PK parameter AUC0-∞ | UP to Day 3 | AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses |
| PK parameter t1/2 | UP to Day 3 | Terminal-phase elimination half-life (t1/2) after single dose and in a steady state after multiple doses |
Countries
China
Contacts
CONTACTWei Qi
Outcome results
None listed