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

NCT05977101 | Unknown

• 1 other identifier: 2021-121
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2; Prevention

Keywords

MY-586 SARS-CoV-2 Neutralizing Antibody

Outcome Measures

Primary Outcomes (4)

• vital signs

  Including pulse, blood pressure, temperature

  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

  Including blood routine, blood biochemistry, routine urine pregnancy test (female) limited

• 12-lead electrocardiogram

  Including ECG QT Interval、PR Interval

  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

  Up to 1 year

Secondary Outcomes (4)

• Drug concentration index

  15 minutes after each dose

• Immunotoxicity detection indicators

  15 minutes after each dose

• Cytokines

  15 minutes after each dose

• lymphocyte subsets

  15 minutes after each dose

Study Arms (2)

MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray

EXPERIMENTAL

Specifications: 5mg/mL, 5mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD

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

Other: Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient

Interventions

MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray BIOLOGICAL

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.

MY-586 SARS-CoV-2 Neutralizing Antibody nasal spray

Placebo Comparator: MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient OTHER

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.

MY-586 SARS-CoV-2 Neutralization Antibody nasal excipient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Study Officials

• Dazhi Zhang, M.D.

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Dazhi Zhang, M.D.

CONTACT

+8613452382818; 300595@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: August 4, 2023
• Study Start: December 17, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)