This is a randomized, double-blind, placebo-parallel intervention clinical study thatwill include approximately 72 healthy subjects based on inclusion and exclusion criteria.Patients who met the inclusion and exclusion criteria were randomly assigned to one ofthree different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1to two parallel dosing groups, one of which served as the control group. Each cohort wasgiven either an experimental drug or a placebo nasal spray at different doses andintervals, and blood was collected on an empty stomach before the first dose, and leftnasal swabs and throat swabs were collected for immunotoxicity and drug concentrationtesting. 14 days after the last dose, subjects will return to the study Center for bloodsamples, left nasal swabs, and throat swabs to be collected for drug concentration,immunotoxicity, and safety laboratory indicators (routine blood and biochemistry). Toevaluate the safety and tolerability of MY-586 SARS-CoV-2 Neutralizing Antibody nasalspray in healthy subjects, and to evaluate its serum concentrations and nasal andpharyngeal swab concentrations by comparing the test results of different cotillaries.
As of December 5, 2021, more than 266 million COVID-19 cases and 5.26 million deaths have
been reported worldwide, according to Worldometer Real-time statistics. On 27 November
2021, a highly mutated new variant of COVID-19 (named Omicron by the WHO) was discovered
in South Africa. Although the introduction of vaccines has played a huge role in the
prevention and control of COVID-19, the neutralizing antibodies stimulated by different
vaccines differ greatly, and the antibody maintains a high titer in the human body for a
short time (3-6 months at most), so the global demand for safe and effective prevention
of COVID-19 remains unmet.
The novel coronavirus neutralizing antibody can directly bind to the envelope of the
novel coronavirus to rapidly block the virus infection, which has been fully verified as
a safe and effective treatment. But so far, there are no approved antibodies at home or
abroad to prevent infection with the novel coronavirus, In addition, there is a lack of
broad-spectrum monoclonal neutralizing antibodies with high efficiency against mutant
strains (currently, all the approved neutralizing antibodies in the world are used in
combination with two antibodies), which can be used as reference for the administration
of neutralizing antibodies for the prevention of a wide range of people (intravenous
infusion as the prophylactic administration will lead to low compliance of the
administration population).
MY-586, a SARS-CoV-2 Neutralizing Antibody, was screened from peripheral blood
lymphocytes of patients recovering from COVID-19, and 209 strains of SARS-CoV-2-specific
antibody were isolated from them, among which MY-586 was a super antibody with strong and
effective neutralizing effect on the novel coronavirus and the circulating strains of UK,
India, South Africa and India Delta.
Currently, the evaluation of the preclinical efficacy and safety of MY-586 SARS-CoV-2
Neutralizing Antibody and the production of CMC to support clinical trials are nearing
completion. All the data showed that MY-586 SARS-CoV-2 Neutralizing Antibody had
excellent efficacy, safety and druggability. In particular, MY-586 SARS-CoV-2
Neutralizing Antibody is administered by nasal spray. Although there are no approved
nasal spray neutralizing antibody drugs on the market at home and abroad, the
investigators have successfully solved the drugging of MY-586 SARS-CoV-2 Neutralizing
Antibody by nasal spray and the development of nasal spray device. The nasal spray type
MY-586 SARS-CoV-2 Neutralizing Antibody is easy to carry, easy to administer, and has
strong accessibility and compliance for the population. It can be used as a new and
widely used safe and effective preventive measure besides vaccines. Therefore, the rapid
clinical research and development of MY-586 SARS-CoV-2 Neutralizing Antibody will provide
a more effective guarantee for social safety and effective prevention of COVID-19.
Biological: MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray
Patients who met the inclusion and exclusion criteria were randomly assigned to one of
three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1
to two parallel dosing groups, one of which served as the control group. Each cohort was
given either an experimental drug or a placebo nasal spray at different doses and
intervals, and blood was collected on an empty stomach before the first dose, and left
nasal swabs and throat swabs were collected for immunotoxicity and drug concentration
testing.
Other: Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient
Patients who met the inclusion and exclusion criteria were randomly assigned to one of
three different cohorts. Subjects in each cohort were randomly assigned in a ratio of 5:1
to two parallel dosing groups, one of which served as the control group. Each cohort was
given either an experimental drug or a placebo nasal spray at different doses and
intervals, and blood was collected on an empty stomach before the first dose, and left
nasal swabs and throat swabs were collected for immunotoxicity and drug concentration
testing.
Inclusion Criteria:
1. Subjects fully understand the purpose, nature, method and possible adverse reactions
of the experiment, voluntarily participate in the experiment, and sign informed
consent before the experiment begins;
2. Healthy subjects aged 18-65 years (including the critical value) with an appropriate
sex ratio between men and women;
3. Body Mass index (BMI) = weight (kg)/height 2 (m2), with a BMI in the range of 19.0
to 30.0 (including the cutoff). Male subjects should weigh at least 50.0kg and
female subjects should weigh at least 45.0kg;
4. The subjects had no birth plan for 3 months from the date of signing the informed
consent to the end of the study, and agreed to voluntarily take effective and
appropriate contraceptive measures with their partners during this period;
5. Negative nucleic acid test of novel coronavirus;
6. Subjects can communicate well with researchers and understand and comply with the
requirements of this study.
Exclusion Criteria:
1. Allergic to any ingredient in this product and auxiliary materials; Or allergic
(such as allergic to two or more drugs, food);
2. Patients with symptoms of acute upper respiratory tract infection within 1 week
before administration;
3. Patients with acute episodes of chronic rhinitis or anatomical abnormalities
affecting drug absorption in the nose;
4. Patients with a history of asthma;
5. Asplenia or functional asplenia caused by any condition;
6. Diseases or factors with clinical abnormalities 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 system and
other systems;
7. Vital signs, physical examination, laboratory examination (such as white blood cell
count less than 3.0*109/L, platelet count less than 75*109/L, TB > 1.5*ULN, ALT >
1*ULN, AST > 1*ULN) and electrocardiogram examination of any items abnormal and
judged by the investigator to be clinically significant;
8. Use of any prescription or over-the-counter drugs within 14 days before
administration;
9. Patients who had received immunosuppressive therapy, cytotoxic therapy or inhaled
corticosteroid therapy within 6 months before administration;
10. A history of drug abuse or use of any drug in the 6 months prior to drug
administration;
11. Pregnant and lactating women;
12. The subject has not taken effective and appropriate contraceptive measures within 30
days before the drug administration;
13. The subjects had sperm and egg donation plans within 3 months after the first drug
administration to the end of the study;
14. Blood donation or massive blood loss (≥200mL), 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;
15. Have participated in other drug clinical trials or device clinical trials, and have
taken test drugs or used test devices within 3 months before drug administration;
16. Subjects may not be able to comply with the protocol to complete the study for other
reasons or the investigator may decide that it is not suitable for participants.
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China
Investigator: Dazhi Zhang, M.D.
300595@hospital.cqmu.edu.cn
Dazhi Zhang, M.D.
+8613452382818
300595@hospital.cqmu.edu.cn
Dazhi Zhang, M.D., Study Chair
The Second Affiliated Hospital of Chongqing Medical University