Corona Virus Disease 2019
Conditions
Interventions
A group:Subjects undergo nebulization inhalation of investigational drugs 60 mg (BM219 or placebo)
B group:Subjects undergo nebulization inhalation of investigational drugs 120 mg (BM219 or placebo)
C group:Subjects undergo nebulization inhalation of investigational drugs 120 mg (BM219 or placebo)
D group:Subjects undergo nebulization inhalation of investigational drugs 180 mg (BM219 or placebo)
E group:Subjects undergo nebulization inhalation of investigational drugs 120 mg, QD (BM219 or placebo)
F group:Subjects undergo nebulization inhalation of investigational drugs 120 mg, BID (BM219 or placebo)
G group:Subjects undergo nebulization inhalation of investigational drugs 180 mg, QD (BM219 or placebo)
experimental group 1:BM219, 120 mg BID
experimental group 2:BM219, 60 mg QD
experimental group 3:BM219, 120 mg QD
Sponsors
The Third Hospital of Changsha
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy subjects: (1) Chinese volunteers aged 18 years or older (inclusive), both male and female. (2) Male volunteers weighing no less than 50 kg, and female volunteers weighing no less than 45 kg; Body Mass Index (BMI) within the range of 19 to 28 (inclusive of the boundary values). BMI = weight (kg) / height² (m²). (3) Volunteers must sign an informed consent form before the trial and fully understand the trial content, procedures, and potential adverse reactions. (4) Volunteers must be able to communicate well with the researchers and understand and comply with all requirements of this study. People infected with novel coronavirus: (1) Age >= 18 years old and <= 70 years old; (2) Gender: Male or Female; (3) Evidence of SARS-CoV-2 infection with clear laboratory records during the screening period: molecular testing (antigen or nucleic acid) of any respiratory specimen (such as oropharyngeal, nasal swab, or saliva) to determine infection; (4) Diagnosed as asymptomatic carrier of SARS-CoV-2, mild or common type of novel coronavirus pneumonia; (5) For asymptomatic carriers, the time from diagnosis to screening should be <= 5 days; For symptomatic patients, the time from symptom onset to screening should be <= 5 days. The symptoms of COVID-19 include fever, cough, nasal congestion or runny nose, sore or dry throat, shortness of breath or difficulty breathing, headache, muscle or body aches, diarrhea, chills, nausea, vomiting, etc. (6) The subjects agree not to participate in other clinical trials during the study period; (7) The subject promises to have no plans to conceive, donate sperm or eggs during the trial period and within 3 months after the last medication, and voluntarily adopt effective physical contraception measures (including partners); (8) Be able to understand the research procedures, potential benefits, and potential risks, and voluntarily participate in the research; Able to communicate well with researchers, comply with the requirements of the entire study, and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Healthy subjects: (1) Subjects who have used other clinical trial medications or devices within 3 months prior to the use of the investigational product, or plan to participate in other clinical trials of medications or devices during this study. (2) Subjects with a history of respiratory diseases such as acute exacerbations of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, interstitial lung disease, bronchial asthma, paradoxical bronchospasm, or throat ulcers, edema, or who have undergone throat, tracheal/bronchial, and lung surgeries in the past, or who have had viral or bacterial upper and lower respiratory tract infections, acute sinusitis, etc., within 4 weeks before using the investigational drug and the investigator considers it clinically significant. (3) Subjects with a history of cardiovascular, digestive, endocrine, urinary, neurological, hematological, immunological (including personal or familial history of inherited immunodeficiency), or metabolic abnormalities that the investigator considers clinically significant at present. (4) Subjects with a history of drug allergies, or specific allergies (such as asthma, urticaria, eczema, etc.), or who are allergic constitution (such as allergy to two or more drugs, foods, and pollens) or are known to be allergic to the components or analogs of the investigational drug. (5) Subjects who are intolerant to venipuncture or have a history of vasovagal syncope. (6) Subjects who have undergone surgeries within 6 months prior to using the investigational drug that the investigator believes will affect drug absorption, distribution, metabolism, or excretion; or who have undergone surgery within 4 weeks before using the investigational drug; or who plan to undergo surgery during the trial. (7) Subjects who have used any medications (including Chinese herbal medicines, health supplements, etc.) within 14 days before using the investigational drug. (8) Subjects who have used any medications within 30 days before using the investigational drug that affect the absorption and metabolism of the investigational drug or interact with it, and the investigator determines them unsuitable for participation in the trial. (9) Subjects who have received vaccinations or live attenuated vaccines within 14 days before using the investigational drug, or plan to receive vaccinations during the trial. (10) Subjects who have donated blood or experienced significant blood loss (>400mL) within 3 months before using the investigational drug, received blood transfusions or blood products, or plan to donate blood or blood components during the trial or within 3 months after the trial. (11) Subjects with drug abuse or who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before using the investigational drug. (12) Smokers or subjects who cannot stop using any tobacco products during the trial. (13) Subjects with alcohol abuse or who have frequently consumed alcohol within 6 months before using the investigational drug, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); or who are unwilling to stop consuming alcohol or any alcohol-containing products during the trial. (14) Subjects who consume excessive amounts of tea, coffee, and/or caffeine-containing beverages daily (more than 8 cups, with 1 cup = 250 mL), or who disagree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Any adverse events that occur during clinical research;Changes in viral load in throat swabs at different time points compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes over time in serum concentrations of BM219;Pharmacokinetic (PK) parameters;Evaluation of the linear relationship between Cmax, AUC, and administered dose;Phase Ia: Comparison of PK parameters after atomization using two different nebulizers;Changes over time in BM219 concentrations in induced sputum;Analysis of the time of onset and titer of anti-drug antibodies (ADA);Proportion of subjects with viral load below the detection limit at each time point;The time from the first administration to the first negative nucleic acid test result;The time from the first appearance of symptoms to the first negative nucleic acid test result;Time to sustained clinical recovery;Progression rate or mortality rate of novel coronavirus pneumonia to severe or critical pneumonia; | — |
Countries
China
Contacts
Public ContactXin Li
The Third Hospital of Changsha
Outcome results
None listed