Healthy Volunteers
Conditions
Keywords
Healthy
Brief summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers
Detailed description
"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence. Part 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."
Interventions
DRUGKLA578-1 for injection
Intravenous injection, single dose
DRUGEtopcoxib Tablets
P.O., single dose
Sponsors
Hunan Kelun Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Health Volunteers (Age: 18\~45 years); 2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0; 3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests; 4. Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.
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 inducers or inhibitors of major CYP450 enzymes 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; 10. Tablet dysphagia; 11. Needle sickness, Hematosickness; 12. Massive blood loss (\> 200 mL) in the past 3 months; 13. Female volunteers are pregnant or lactating; 14. History of unprotected sex within 2 weeks; 15. Special requirements for diet; 16. Heavy smoker ( more than 3 cigarettes/day) within 3 months; 17. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months; 18. Heavy caffeine intake; 19. History of grapefruit, xanthine-rich foods intake within 7 days; 20. Positive alcohol test; 21. Positive drugs of abuse test result.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) | Up to day 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter Cmax | single dose：up to Day 6 ; multiple doses: up to Day 8 | Maximum peak plasma concentration (Cmax) after single dose and in a steady state after multiple doses |
| PK parameter Tmax | single dose：up to Day 6 ; multiple doses: up to Day 8 | Time of Cmax (Tmax) after single dose and in a steady state after multiple doses |
| PK parameter Cmin,ss | multiple doses: up to Day 1 | The trough concentration observed during the drug administration interval in a steady state (Cmin,ss) after multiple doses |
| PK parameter AUC0-t | single dose：up to Day 6 ; multiple doses: up to Day 8 | 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-∞ | single dose：up to Day 6 ; multiple doses: up to Day 8 | AUC from time zero to infinity (AUC0-∞) after single dose and in a steady state after multiple doses |
| PK parameter AUCtau,ss | multiple doses: up to Day 1 | AUC for the drug administration interval in a steady state (AUCtau,ss) after multiple doses |
| PK parameter t1/2 | single dose：up to Day 6 ; multiple doses: up to Day 8 | 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