Paroxysmal nocturnal haemoglobinuria
Conditions
Interventions
Experimental group:Rosuvastatin calcium tablets (victim drug): Administered once on the morning of D1 and D11 in a fasted state (D11 co-administered with NTQ5082 capsules), with a single dose of 10 mg
Sponsors
Xiangya Third Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Trial participants must meet all of the following criteria to be eligible for this study: 1. Healthy males or females aged >=18 years and <=45 years (inclusive); 2. Body mass index (BMI) between 19.0 kg/m^2 and 26.0 kg/m^2, with a minimum weight of 50 kg for males and 45 kg for females; 3. Signed informed consent prior to the trial and fully understand the study content, procedures, and potential adverse effects; 4. Able to communicate effectively with the investigators and understand and comply with all study requirements; 5. Voluntarily receive the ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days prior to the first dose. If the pneumococcal vaccine was administered within the past 5 years or the ACYW135 meningococcal vaccine within the past 3 years, repeat vaccination is not required.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will not be included in this study: 1. Those who participated in any other drug clinical trials within the previous 3 months and used the investigational drug; 2. Those who had chronic or active digestive tract diseases such as esophageal diseases, gastritis, gastric ulcers, gastroesophageal reflux, enteritis, active gastrointestinal bleeding or digestive tract surgery within the previous 3 years, and the investigator considers it still clinically significant at present; 3. Those with definite diseases in the central nervous system, cardiovascular system, digestive system, respiratory system (such as interstitial lung disease), endocrine system (such as diabetes), urinary system (such as renal function impairment), hematological and lymphatic system, metabolic disorders, etc., and require medical intervention or other diseases that are not suitable for participating in clinical trials (such as a history of mental illness, etc.); 4. Those with known or suspected history of immunodeficiency diseases (for example, a history of frequent recurrent infections), hereditary or acquired complement deficiency history; 5. Those who have a clear history of capsule microbial infection within the previous 6 months, including but not limited to: Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila infection history, etc.; 6. Those with a previous history of tuberculosis infection or those currently suffering from tuberculosis; 7. Those with active liver diseases, obstructive gallbladder, biliary tract diseases, personal or family history of hereditary muscle diseases, rhabdomyolysis-related history, and the investigator considers it still clinically significant at present; 8. Those with a history of muscle toxicity caused by using another HMG-CoA reductase inhibitor or fibrates; 9. Those who have active systemic bacterial, viral or fungal infection within 14 days before the first administration; 10. Those who have muscle pain, dizziness, headache, abdominal pain, diarrhea, constipation symptoms within 14 days before the first administration, and the investigator considers it inappropriate to participate in the trial; 11. Those who have an allergy to the investigational formulation and any of its components or related preparations, or have a history of drug, food or other substance allergies; 12. Those who cannot tolerate venipuncture or have a history of fainting or needle shock; 13. Those who have undergone surgery judged by the investigator to affect drug absorption, distribution, metabolism, and excretion within the previous 6 months; or within 30 days before the admission; or those who plan to undergo surgery during the trial; 14. Those who have used any drug within 28 days before the admission (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, Chinese patent medicines and dietary supplements, etc.); or those whose drug half-life has not exceeded 5 half-lives at the time of screening (with the longer time being the criterion); 15. Those who have received vaccines or attenuated live vaccines (meningococcal vaccine and pneumococcal vaccine excluded) within 14 days before the first administration, or those who plan to receive vaccines during the trial; 16. Those with a QTc >= 450 msec (for males) or QTc >= 460
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;12-lead ECG; | — |
Countries
China
Contacts
Public ContactYang Guoping
Xiangya Third Hospital of Central South University
Outcome results
None listed