COVID-19
Conditions
Interventions
Cohort 1:MY-586 SARS-CoV-2 Neutralizing Antibody Nasal Spray
Cohort 2:MY-586 SARS-CoV-2 Neutralizing Antibody Nasal Spray
Cohort 3:MY-586 SARS-CoV-2 Neutralizing Antibody Nasal Spray
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy people aged 18 years and above, both male and female; 2. The subjects voluntarily participate in the study, sign the informed consent, provide valid identification, and understand and comply with the requirements of the test protocol; 3. Women of childbearing age had taken effective contraceptive measures within 2 weeks before joining the study, and the pregnancy test results were negative before enrollment. All subjects voluntarily agreed to use effective contraceptive methods from the signing of the informed consent to the end of the study period (effective contraceptive methods include: oral contraceptives (excluding emergency contraception), injected or embedded contraception, sustained release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), diaphragm, cervical caps, etc.); 4. Those with negative nucleic acid test of SARS-CoV-2 during the screening period. (All above requirements must be met to be included in the test)
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal vital signs, physical examination, laboratory examination and electrocardiogram examination and judged by researchers to be clinically significant; 2. Allergic to any ingredient in this product and auxiliary materials; Or allergic (such as allergic to two or more drugs, food); 3. Previous history of SARS, SARS-CoV-2, MERS, or other human coronavirus infection or disease; 4. Patients who could not tolerate intranasal administration; 5. Used any nasal spray, nasal inhalation or other nasopharyngeal products within 2 months before screening, or could not stop using such products during the test period; 6. Patients who have received any nasopharyngeal surgery within 1 year, have acute episodes of chronic rhinitis in the past or have anatomical abnormalities in the nose that affect drug absorption; 7. Diseases or factors with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone and other systems, such as: (1) Acute attacks of various acute diseases or chronic diseases within the last 7 days; (2) Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; (3) A history of congenital or acquired immune deficiency or autoimmune disease; (4) Serious or uncontrollable or inpatient cardiovascular diseases, diabetes, neurological diseases (such as Guillain-Barre syndrome), diseases of the blood and lymphatic system, immune system, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; (5) Serious nasal or oral diseases or symptoms, such as acute rhinitis (sinusitis), allergic rhinitis, mouth ulcers, throat redness and swelling; (6) Abnormal lung function, such as asthma, chronic obstructive pulmonary disease and pulmonary fibrosis; 8. Drug or alcohol abuse, which the investigators believe may affect the safety and efficacy assessment of the subjects or compliance with the study; 9) Lactating or pregnant women; 10. Who are participating in other COVID-19 related clinical trials, and who are or plan to participate in other clinical trials during the study period; 11. Blood donation or massive blood loss (>= 200 mL), receiving blood transfusion or using blood products within 3 months prior to drug administration; Or plan to donate blood or blood components during the trial; 12. Use of any prescription or over-the-counter drugs within 14 days prior to administration; 13. The investigator considers that the subject has any disease or condition that would place the subject at an unacceptable risk; The subject is unable to meet the protocol requirements; A condition that interferes with the assessment of response to a drug. (Compliance with any of the above is not included in the test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Tolerability;Drug concentration in nasal swab;Drug concentration in throat swab;Pharmacokinetics;Drug concentration in serum; | — |
Countries
China
Contacts
Public ContactZhang Dazhi
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed