To evaluate the safety, tolerance, local drug content and neutralization activity innasal cavity, systemic exposure level and immunogenicity of novel coronavirusbroad-spectrum neutralizing antibody SA55 nasal spray.
Not Provided
Drug: SA55 nasal spray
The novel coronavirus broad-spectrum neutralizing antibody SA55 nasal spray (SA55 nasal
spray) is provided by Beijing Kexing Zhongwei Biotechnology Co., Ltd. The main component
of this product is the novel coronavirus broad-spectrum neutralizing antibody, which is a
colorless to pale yellow solution. Each milliliter contains 5mg of broad-spectrum
neutralizing antibody against novel coronavirus. Excipients include histidine
hydrochloride, arginine hydrochloride, histidine, sucrose, polysorbate 80 (II),
hydroxypropyl cellulose, glycerol, and benzalkonium chloride (concentration 0.005%).
20 sprays per bottle, approximately 100 sprays per bottle μ L. Containing 0.5 mg of
broad-spectrum neutralizing antibody against novel coronavirus.
Inclusion Criteria:
- Male or female aged 18-65 on the day of enrollment;
- Overall good health condition, with no significant abnormalities during screening
and/or pre medication physical examinations;
- Male subjects weighing ≥ 50.0kg; Female subjects with a weight of ≥ 45.0kg and a BMI
between 18.0-28.0kg/m2 (including boundary values);
- The subjects (males and females with fertility potential) and their sexual partners
have no fertility plan from 4 weeks before screening to 3 months after the last
administration of the investigational drug, voluntarily take effective contraceptive
measures, and have no plans to donate sperm or eggs;
- Volunteer to participate in the experiment, cooperate with the visit, and sign an
informed consent form before the start of the study.
Exclusion Criteria:
- Individuals who are known to be allergic to the investigational drug, any component
in the preparation, or other similar drugs;
- Individuals with a history of severe allergies or sensitivity to inhaled allergens,
including but not limited to allergic rhinitis, bronchial asthma, etc;
- Previous history of sinus and septum surgery or radiotherapy;
- Patients with nasal diseases that may affect the deposition/absorption of drugs in
the nose (such as narrowing of the nasal vestibule, severe deviation, perforation,
ulcer of the nasal septum, thickening, pallor, edema, erosion of the nasal mucosa,
hypertrophy and atrophy of the nasal wings, accumulation of fluid and pus in the
nasal cavity, and space occupying or vegetation in the nasal cavity);
- Abnormal examination of the oropharynx has clinical significance, such as
congestion, thickening, ulcers, hyperplasia or nodules, new organisms or foreign
bodies of the throat mucosa;
- The following symptoms or diseases with clinical significance: a) a history of
long-term nasal congestion, runny nose, headache, nosebleed, and other symptoms; b)
Asthma, chronic respiratory diseases, etc; c) History of allergic rhinitis, chronic
rhinitis, and sinusitis; d) History or signs of nasal, pharyngeal, and upper
respiratory diseases that other researchers believe may affect the interpretation of
the research process and/or local adverse events;
- Suffering from severe neurological disorders (epilepsy, seizures or convulsions) or
mental illness, with a family history of mental illness, and neurological and
psychiatric problems associated with various organic disorders;
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation
disorders, platelet abnormalities) or obvious bruising or coagulation disorders
diagnosed by a doctor;
- Other uncontrolled chronic or severe disease history, including but not limited to
cardiovascular disease, hematological system disease, liver and kidney disease,
digestive system disease, respiratory system disease, malignant tumor, history of
major organ transplantation, HIV/HBV/HCV/syphilis infection, or any other disease or
physiological condition that the researcher believes can interfere with the test
results;
- Planned pregnancy within 3 months, already pregnant (including positive pregnancy
test), or breastfeeding;
- Received any SARS-CoV-2 neutralizing antibody injection that has been marketed or
under research within 180 days prior to screening, or participated in clinical
trials of other drugs or medical devices within 90 days prior to screening;
- Individuals who are unable to cooperate with nasal spray inhalation, nasal swab
sampling, and venous blood collection, or who require long-term/intermittent use of
any nasal products;
- Those with a body temperature above 37.0 ℃ before the first medication;
- 4 weeks prior to screening for clinically significant acute or chronic disease
exacerbations, or a history of surgery;
- Known to have a history of SARS-CoV-2 infection within 3 months;
- Within 90 days before the first medication, blood donation>400 mL or significant
blood loss>400 mL; Or donate plasma within 30 days before the first medication;
- Within 180 days prior to screening, use of immunoglobulins or blood products, immune
modulators (such as adrenocortical hormones and thymosin) α Or blood stimulating
drugs;
- Have been inoculated with any marketed or under research COVID-19 nasal spray
vaccine within 180 days before screening, or have been inoculated with any marketed
or under research COVID-19 vaccine within 90 days;
- Received attenuated live vaccine within 14 days prior to screening, or received
subunit or inactivated vaccine within 7 days;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal
medicines, and functional vitamins within the first 14 days of screening;
- Smokers who smoke ≥ 5 cigarettes per day within the first 3 months of screening, or
who cannot guarantee giving up smoking during the trial period;
- Drinking more than 14 units (1 unit of alcohol is equivalent to 360 mL of beer, 150
mL of wine, or 45 mL of Baijiu) per week within 3 months before screening, or not
abstaining from alcohol during the test, or having a history of alcohol abuse within
2 years, or positive alcohol breath test before enrollment;
- There is a history of drug abuse or dependence or recreational drug use within 2
years prior to screening, or a positive urine drug abuse screening before
enrollment.
- According to the judgment of the researchers, the subjects have any other factors
that are not suitable for participating in clinical trials.
Beijing Ditan Hospital Capital Medical University
Beijing, Chaoyang, China
Investigator: Ronghua Jin, M.D.
Contact: 010-84323059
ronghuajin@ccmu.edu.cn
Investigator: Ronghua Jin, M.D.
Ronghua Jin, M.D.
010-84323059
ronghuajin@ccmu.edu.cn
Ronghua Jin, M.D., Principal Investigator
Beijing Ditan Hospital