First-in-Human Single and Multiple Dose of KLA578-1 for Injection
Trial Parameters
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
Eligibility Criteria
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 die