SARS-CoV-2NCT05977101
The Safety and Tolerability of MY-586 COVID-19 Neutralizing Antibody Nasal Spray in Healthy Subjects
A study testing MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray in people with SARS-CoV-2 and Prevention, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Prevention
- What is being tested?
- MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- Healthy subjects aged 18-65 years (including the critical value) with an appropriate sex ratio between men and women;
- 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;
- 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;
- Negative nucleic acid test of novel coronavirus;
- Subjects can communicate well with researchers and understand and comply with the requirements of this study.
Who cannot join
- Allergic to any ingredient in this product and auxiliary materials; Or allergic (such as allergic to two or more drugs, food);
- Patients with symptoms of acute upper respiratory tract infection within 1 week before administration;
- Patients with acute episodes of chronic rhinitis or anatomical abnormalities affecting drug absorption in the nose;
- Patients with a history of asthma;
- Asplenia or functional asplenia caused by any condition;
- 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;
Show all 16Show fewer
- 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;
- Use of any prescription or over-the-counter drugs within 14 days before administration;
- Patients who had received immunosuppressive therapy, cytotoxic therapy or inhaled corticosteroid therapy within 6 months before administration;
- A history of drug abuse or use of any drug in the 6 months prior to drug administration;
- Pregnant and lactating women;
- The subject has not taken effective and appropriate contraceptive measures within 30 days before the drug administration;
- The subjects had sperm and egg donation plans within 3 months after the first drug administration to the end of the study;
- 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;
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Dazhi Zhang, M.D., 300595@hospital.cqmu.edu.cn
About this study
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
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.
Read the detailed 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.
- Conditions
- SARS-CoV-2, Prevention
- Being tested
- MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray, Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient
- Keywords
- MY-586 SARS-CoV-2 Neutralizing Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY-586 SARS-CoV-2 Neutralizing Antibody nasal sprayBiological
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.
Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipientOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray | Experimental | Specifications: 5mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD Receives: Biological: MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray |
| MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient | Placebo comparator | Specifications: 0mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD Receives: Other: Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital signs
Including pulse, blood pressure, temperature
Measured: 14 days before the trial,1 days before the trial, after each dose
laboratory tests
Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited
Measured: Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited
12-lead electrocardiogram
Including ECG QT Interval、PR Interval
Measured: 14 days before the trial,1 days before the trial, after each dose
adverse events
Adverse reactions were recorded by questionnaire. Observe any adverse events
Measured: Up to 1 year
Secondary outcomes (4)
Drug concentration index
Drug concentration of serum, nasal swab and pharyngeal swab
Measured: 15 minutes after each dose
Immunotoxicity detection indicators
Serum autoantibody titer
Measured: 15 minutes after each dose
Cytokines
Serum Cytokines titer
Measured: 15 minutes after each dose
lymphocyte subsets
Serum lymphocyte subsets
Measured: 15 minutes after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start17 Dec 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dazhi Zhang, M.D., Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977101
- Sponsor's protocol ID
- 2021-121
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05977101
- Acronym / sponsor ID
- 2021-121
- Conditions
- SARS-CoV-2, Prevention
- Keywords
- MY-586 SARS-CoV-2 Neutralizing Antibody
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray | Experimental | Biological: MY-586 SARS-CoV-2 Neutralizing Antibody nasal spraySpecifications: 5mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD |
| MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient | Placebo comparator | Other: Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipientSpecifications: 0mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- Healthy subjects aged 18-65 years (including the critical value) with an appropriate sex ratio between men and women;
- 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;
- 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;
- Negative nucleic acid test of novel coronavirus;
Key exclusion criteria (16 listed)
- Allergic to any ingredient in this product and auxiliary materials; Or allergic (such as allergic to two or more drugs, food);
- Patients with symptoms of acute upper respiratory tract infection within 1 week before administration;
- Patients with acute episodes of chronic rhinitis or anatomical abnormalities affecting drug absorption in the nose;
- Patients with a history of asthma;
- Asplenia or functional asplenia caused by any condition;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY-586 SARS-CoV-2 Neutralizing Antibody nasal sprayPatients 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. | Biological | MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray |
| Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipientPatients 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 | MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient |
Primary outcome
vital signs
Time frame: 14 days before the trial,1 days before the trial, after each dose
Including pulse, blood pressure, temperature
laboratory tests
Time frame: Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited
Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited
12-lead electrocardiogram
Time frame: 14 days before the trial,1 days before the trial, after each dose
Including ECG QT Interval、PR Interval
adverse events
Time frame: Up to 1 year
Adverse reactions were recorded by questionnaire. Observe any adverse events
4 secondary outcomes
Drug concentration index
Time frame: 15 minutes after each dose
Immunotoxicity detection indicators
Time frame: 15 minutes after each dose
Cytokines
Time frame: 15 minutes after each dose
lymphocyte subsets
Time frame: 15 minutes after each dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dazhi Zhang, M.D. study chair
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray in people with SARS-CoV-2 and Prevention, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dazhi Zhang, M.D. (+8613452382818, 300595@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital signs (time frame: 14 days before the trial,1 days before the trial, after each dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.