Respiratory Syncytial Virus
Conditions
Interventions
Group A:AK1012 dose 1 or placebo (2:1)
Group B:AK1012 dose 2 or placebo (2:1)
Group C:AK1012 dose 3 or placebo (4:1)
Group D:AK1012 dose 4 or placebo (4:1)
Group E:AK1012 dose 5 or placebo (4:1)
Group F:AK1012 dose 6 or placebo (2:1)
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Subjects voluntarily sign the written informed consent before starting the trial, and fully understand the content, process and possible adverse reactions of the trial; voluntarily participate in and be able to complete the trial in accordance with the requirements of the trial protocol; (2) Healthy subjects (both male and female) aged =18 years and =45 years (based on the date of signing the informed consent); (3) Men should weigh no less than 50.0 kg and women should weigh no less than 45.0 kg, with a body mass index (BMI) within the range of 18.0 to 26.0 (including the threshold value) [BMI = weight (kg)/height2 (m2)]; (4) Good health condition, all results of physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray, and laboratory tests are normal or abnormal without clinical significance, as judged by the investigator to be eligible; (5) From 14 days prior to the screening period, the subject or his/her spouse need to use appropriate and effective contraceptive measures, such as abstinence, intrauterine device (IUD), double barrier method (e.g., condom plus diaphragm), etc., and they have no plan to donate sperm or eggs, and to ensure that there is no plan for childbearing from the start of the trial to 3 months after the last administration of study drug.
Exclusion criteria
Exclusion criteria: (1) Persons with clinically significant diseases of the nervous system, psychiatric system, cardiovascular and cerebrovascular system, digestive system, blood and lymphatic system, urinary system, endocrine system, immune system, or any other diseases and physiological conditions that may affect the results of the trial; (2) Persons with allergic constitution; persons who have suffered or are suffering from clinically significant allergic reactions, hypersensitivity reactions or allergic reactions, including persons who are known or suspected to be allergic to a component of the test drug; (3) Persons with C-reactive protein greater than the upper limit of normal at screening; (4) Persons with a history of drug use or substance abuse; (5) Persons who are unable to use a nebulized inhalation device properly or who cannot tolerate or accept nebulized inhalation administration; (6) Persons who cannot tolerate bronchoalveolar lavage (Phase II subjects only); (7) Persons who have a history of respiratory disease judged by the investigator to be clinically significant (including, but not limited to, acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, interstitial lung disease, bronchial asthma, paradoxical bronchospasm, pharyngeal ulcers, edema, etc.); or have had previous surgery on the larynx, trachea/bronchus, and lungs; or have developed a viral or bacterial-induced, within the 4-week period prior to the administration of study medication upper or lower respiratory tract infection, acute sinusitis, or other illnesses that are considered clinically significant by the investigator or inappropriate for participation in the trial; (8) Persons with abnormal lung function (measured first second expiratory volume with exertion [FEV1]/predicted value of FEV1 = 80% or measured value of forceful lung capacity [FVC]/predicted value of FVC = 80%); (9) Those who have undergone surgery within 3 months prior to the Screening Period or plan to undergo surgery during the trial period, or those who have undergone surgery that would affect drug absorption, distribution, metabolism, or excretion; (10) Individuals who will have been vaccinated within 4 weeks prior to the first dose, during the treatment period, or are scheduled to be vaccinated within 30 days of the final dose; (11) Persons who have taken any prescription, over-the-counter, herbal, and nutraceutical medications within 2 weeks prior to screening; (12) Persons who have participated in a clinical trial of another drug and received administration within 3 months prior to screening, or who plan to participate in another clinical trial at the same time during this trial; (13) Those who have donated blood or blood products or lost = 400 mL of blood within 3 months prior to screening or plan to do so during the trial (except for female physiologic bleeding); (14) Those who have smoked an average of >5 cigarettes per day in the 3 months prior to screening or who are unable to stop using any tobacco-based products during the trial; (15) Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol by volume or 150 mL of wine) in the 3 months prior to screening, or who have taken any alcohol-containing product within 24 hours prior to dosing, or who are unable to abstain from alcohol during the trial period, or who have a positive alcohol test result; (16) Persons who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome (adverse events, physical examination, vital sign, experiment examination, lung function examination,etc);immunogenicity outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed