The Safety and Tolerability of MY-586 COVID-19 Neutralizing Antibody Nasal Spray in Healthy Subjects

SARS-CoV-2 Clinical Trial

Official title: A Randomized, Double-blind, Placebo-parallel Controlled Clinical Study to Evaluate the Safety and Tolerability of MY-586 SARS-CoV-2 Neutralizing Antibody Nasal Spray in Healthy Subjects

Status Recruiting

Clinical Trial Summary

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 72 healthy subjects based on inclusion and exclusion criteria. 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. 14 days after the last dose, subjects will return to the study Center for blood samples, left nasal swabs, and throat swabs to be collected for drug concentration, immunotoxicity, and safety laboratory indicators (routine blood and biochemistry). To evaluate the safety and tolerability of MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray in healthy subjects, and to evaluate its serum concentrations and nasal and pharyngeal swab concentrations by comparing the test results of different cotillaries.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Prevention
• SARS-CoV-2

• NCT number: NCT05977101
• Study type: Interventional
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Dazhi Zhang, M.D.
• Phone: +8613452382818
• Email: 300595@hospital.cqmu.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Completion date: December 30, 2023