The Safety and Tolerability of A8G6 COVID-19 Neutralization Antibody Combined With Nasal Spray

NCT06127498 | Unknown

• 1 other identifier: 2022-69
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 108 healthy subjects based on inclusion and exclusion criteria. Patients meeting inclusion and exclusion criteria were randomly assigned to one of four different cohorts. Subjects in each cohort were randomly assigned 5:1 to two parallel administration groups, one of which served as a control. Each cohort was given either the experimental drug or placebo by nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose. Right nostril and nasal swabs were collected for immunotoxicity, immunogenicity (immunogenicity collection and detection in cohorts 3 and 4 only), and drug concentration detection. Subjects in the first three cohort were required to return to the study Center 3±1 days after the last dose for blood samples, bilateral nostril and nasal swabs for drug concentration, immunotoxicity, physical examination, vital signs, and safety laboratory indicators (blood routine, blood biochemical, and urine routine). Subjects in cohort 4 returned to the study center 7±2 days after the last dose. To evaluate the safety and tolerability of A8G6 COVID-19 neutralization and antibody combined nasal spray in healthy subjects by comparing the test results of subjects in different cohorts, and to study its concentration in serum and nasal swabs in healthy subjects.

Conditions

SARS-CoV-2; Prevention

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

  14 days before the trial,1 days before the trial, after each dose

• 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 (5)

• Drug concentration index

  15 minutes after each dose

• Immunotoxicity detection indicators

  15 minutes after each dose

• Immunogenicity detection indicators

  15 minutes after each dose

• Cytokines

  15 minutes after each dose

• lymphocyte subsets

  15 minutes after each dose

Study Arms (2)

A8G6 SARS-CoV-2 Neutralization Antibody combination nasal spray

EXPERIMENTAL

Specifications: 5 mg/mL, 6 mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD

Biological: A8G6 SARS-CoV-2 Neutralization Antibody combination nasal spray

A8G6 SARS-CoV-2 Neutralization Antibody nasal excipient

PLACEBO COMPARATOR

Specification: 0 mg/mL, 6 mL/ bottle; Provided by Chongqing Mingdao Haoyue Biotechnology Co., LTD

Other: A8G6 SARS-CoV-2 Neutralization Antibody nasal excipient

Interventions

A8G6 SARS-CoV-2 Neutralization Antibody combination nasal spray BIOLOGICAL

Subjects in each cohort were randomly assigned 5:1 to two parallel administration groups, one of which served as a control. Each cohort was given either the experimental drug or placebo by nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose. Right nostril and nasal swabs were collected for immunotoxicity, immunogenicity (immunogenicity collection and detection in cohorts 3 and 4 only), and drug concentration detection. Subjects in the first three cohort were required to return to the study Center 3±1 days after the last dose for blood samples, bilateral nostril and nasal swabs for drug concentration, immunotoxicity, physical examination, vital signs, and safety laboratory indicators (blood routine, blood biochemical, and urine routine). Subjects in cohort 4 returned to the study center 7±2 days after the last dose.

A8G6 SARS-CoV-2 Neutralization Antibody combination nasal spray

A8G6 SARS-CoV-2 Neutralization Antibody nasal excipient OTHER

Subjects in each cohort were randomly assigned 5:1 to two parallel administration groups, one of which served as a control. Each cohort was given either the experimental drug or placebo by nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose. Right nostril and nasal swabs were collected for immunotoxicity, immunogenicity (immunogenicity collection and detection in cohorts 3 and 4 only), and drug concentration detection. Subjects in the first three cohort were required to return to the study Center 3±1 days after the last dose for blood samples, bilateral nostril and nasal swabs for drug concentration, immunotoxicity, physical examination, vital signs, and safety laboratory indicators (blood routine, blood biochemical, and urine routine). Subjects in cohort 4 returned to the study center 7±2 days after the last dose.

A8G6 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;
• 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;
• The subject agrees that from the beginning of the study (-1 day) to the end of the study, except for this study, only samples of NCOV nucleic acid from throat swabs will be taken, and nasal swabs will not be taken;
• The subjects had not received any type of NCOV vaccine within 3 months prior to enrollment, and had no NCOV vaccination plan during the study period;
• 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

+86 13452382818; 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: November 13, 2023
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)