None
Conditions
Interventions
1:2ml 0.9% sodium chloride injection+ 0.5ml PEG-IFNa-2b (Specification: 90µg/ piece)
2:2ml 0.9% sodium chloride injection+ 0.5ml PEG-IFNa-2b (Specification: 180µg/ piece)
3:2ml Ambroxol hydrochloride solution for inhalation(15mg)+ 0.5ml PEG-IFNa-2b (Specification: 90µg/ piece)
Sponsors
Xiamen Humantiy Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1)The subjects can understand and abide by the contents, requirements and restrictions of the program, are willing and able to complete the study in accordance with the requirements of the program, fully understand the possible adverse reactions, and voluntarily sign informed consent before the study; (2) The age of signing the informed consent is 18-50 years old (including the critical value), and the gender is not limited; (3) Female weight =45kg, male weight =50kg, body mass index (BMI) 18.5~28kg/m2 (including the critical value); (4) The pregnancy test results of fertile women at the time of screening are negative; (5) The subject (including the partner) voluntarily takes effective, non-drug contraceptive measures from before to 3 months after the administration of the drug and has no sperm donation or egg donation plan; Or the subject (including the partner) is infertile (surgically sterilized or menopausal).
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women or having a family plan during the study period; (2) Abnormalities in physical examination, vital signs, laboratory examination have clinical significance; (3) Pulmonary function examination: FEV1 measured value /FEV1 estimated value =80% or FVC= 80% of the estimated value; (4) Have a history of cardiovascular system, blood and lymphatic system, respiratory system, urinary system, endocrine system, immune system, mental system, nervous system (such as epilepsy) and other diseases, and have clinical significance; (5) Have a history of eye disease or thyroid related disease, and the investigator considers it clinically significant; (6) Alcohol/drug abuse, blood donation, or significant blood loss (> 450mL) within 3 months prior to screening; (7) Known or suspected allergy to the investigational drug or excipient; (8) Have participated in other interventional clinical trials within 3 months before screening, or plan to participate in other clinical trials during the study period; Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics (PK);pharmacodynamics (PD);Blood concentration, neocerin; | — |
Countries
China
Contacts
Public ContactWenqi Huang
Xiamen Humantiy Hospital
Outcome results
None listed