Paroxysmal Nocturnal Hemoglobinuria,PNH
Conditions
Interventions
Group 1 :90 mg test drug
Group 2:180 mg test drug
Group 3:360 mg test drug vs placebo
Group 4:720 mg test drug vs placebo
Group 5:1440 mg test drug vs placebo
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18 - 55 years (including upper and lower limits), regardless of gender. 2. Weight =50kg for male or =45kg for female and a body mass index (BMI) of 18-28kg/m2 (including upper and lower limits). 3. Systolic and diastolic blood pressure within normal limits or abnormal but not clinically significant. 4. The meningococcal polysaccharide vaccine MenACWY (containing four serotypes A, C, W and Y) vaccine was administered at least two weeks prior to dosing. 5. The subject is able to communicate well with the investigator and is able to complete the study in accordance with the protocol. 6. The subject is cosiderated by investigator to be in good health condition based on physical examination, medical history, vital signs, ECG, chest radiograph, abdominal ultrasound and laboratory findings. 7. Male subjects agree to use effective contraception (effective contraception includes: vasectomy, abstinence, condom use) during the entire study period (from screening period to 6 months after the end of the trial). Female subjects must have a negative blood pregnancy test at screening and baseline period. Female and male subjects and their sexual partners must agree to use contraception (contraception excluding medication) during the trial and for 6 months after the end of the trial. 8. Subjects must read informed consent of the study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous severe drug allergic reactions, a clear history of allergy and/or hypersensitivity to the test drug and its components, assessed by the investigator as unsuitable for participation in this study. 2. Previous history of splenectomy. 3. Previous history of tuberculosis. 4. Congenital or acquired complement deficiency disease. 5. Any contraindication to antibiotic (beta-lactam antibiotics, ciprofloxacin, etc.) prophylaxis for meningococcal infection. 6. Positive hepatitis C virus antibody, positive human immunodeficiency virus (HIV) antibody, positive anti-syphilis spiral antibody (TP-Ab) and positive hepatitis B virus (HBV) surface antigen at screening. 7. Presence of symptoms or history of any significant disease, including but not limited to cardiac, hepatic, renal or other acute or chronic gastrointestinal or respiratory disease, as well as hematological, endocrine, neurological, psychiatric or other systemic diseases, or any other disease or physiological condition capable of interfering with the study results. 8. Those who have participated in a clinical trial of any drug or medical device within 3 months prior to the screening period, or those who are still within 5 half-lives of other experimental drugs prior to screening (whichever is longer). 9. Those who have lost or donated >400mL of blood within 3 months prior to the screening period or >200mL of blood within 4 weeks or plan to donate blood during the trial. 10. Smokers consume an average of =5 cigarettes per day in the 3 months prior to the trial. 11. Heavy drinker or regular drinker within 6 months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine) or positive blood alcohol test during the screening period. 12. Previous history of drug or substance abuse, or a positive substance abuse screen results at screening period. 13.Surgical procedure, blood or blood component transfusion within 1 month prior to screening. 14. Live or live attenuated vaccine received within 1 month prior to the first dosing. 15. Any prescription, over-the-counter, herbal and vitamin use within 14 days or 5 drug half-lives (whichever is longer) prior to screening. 16. Active infection (including viral, bacterial or fungal infection) including herpes, herpes zoster within 14 days prior to drug administration. 17. Fever (=38°C) within 7 days prior to the first dosing. 18. Pregnant or lactating women or female subjects who have had unprotected sexual intercourse within 14 days. 19. Other reasons lead to unable to complete the study or deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome (vital signs, physical examination, laboratory tests, ECG tests, adverse reactions); | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome ;PD outcome ; | — |
Countries
China
Contacts
Public ContactWei hu
The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed