SA55 Novel Coronavirus Broad-spectrum Neutralizing Antibody Nasal Spray in Health People

NCT06048393 | Unknown Phase 1

• 1 other identifier: PRO-SA55-1002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerance, local drug content and neutralization activity in nasal cavity, systemic exposure level and immunogenicity of novel coronavirus broad-spectrum neutralizing antibody SA55 nasal spray.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of SA55 nasal spray

  The incidence and types of adverse events during the study period

  1 month

Secondary Outcomes (2)

• To evaluate the local drug content and neutralization activity in the nasal cavity at different time points after single and multiple administration of SA55 nasal spray

  1 month

• To evaluate the systemic exposure level of SA55 nasal spray after single and multiple administration

  1 month

Study Arms (2)

Group1

EXPERIMENTAL

Single-dose:1 spray per side per time, 1ml/time Single-dose: 2 sprays per side per time, 2ml/time Multi-dose:1 spray per side per time, 1ml/time Multi-dose: 2 sprays per side per time, 2ml/time

Drug: SA55 nasal spray

Group2

PLACEBO COMPARATOR

Single-dose: 1 spray per side per time Multi-dose: 2 sprays per side per time

Drug: SA55 nasal spray

Interventions

SA55 nasal spray DRUG

The novel coronavirus broad-spectrum neutralizing antibody SA55 nasal spray (SA55 nasal spray) is provided by Beijing Kexing Zhongwei Biotechnology Co., Ltd. The main component of this product is the novel coronavirus broad-spectrum neutralizing antibody, which is a colorless to pale yellow solution. Each milliliter contains 5mg of broad-spectrum neutralizing antibody against novel coronavirus. Excipients include histidine hydrochloride, arginine hydrochloride, histidine, sucrose, polysorbate 80 (II), hydroxypropyl cellulose, glycerol, and benzalkonium chloride (concentration 0.005%). 20 sprays per bottle, approximately 100 sprays per bottle μ L. Containing 0.5 mg of broad-spectrum neutralizing antibody against novel coronavirus.

Group1; Group2

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18-65 on the day of enrollment;
• Overall good health condition, with no significant abnormalities during screening and/or pre medication physical examinations;
• Male subjects weighing ≥ 50.0kg; Female subjects with a weight of ≥ 45.0kg and a BMI between 18.0-28.0kg/m2 (including boundary values);
• The subjects (males and females with fertility potential) and their sexual partners have no fertility plan from 4 weeks before screening to 3 months after the last administration of the investigational drug, voluntarily take effective contraceptive measures, and have no plans to donate sperm or eggs;
• Volunteer to participate in the experiment, cooperate with the visit, and sign an informed consent form before the start of the study.

You may not qualify if:

• Individuals who are known to be allergic to the investigational drug, any component in the preparation, or other similar drugs;
• Individuals with a history of severe allergies or sensitivity to inhaled allergens, including but not limited to allergic rhinitis, bronchial asthma, etc;
• Previous history of sinus and septum surgery or radiotherapy;
• Patients with nasal diseases that may affect the deposition/absorption of drugs in the nose (such as narrowing of the nasal vestibule, severe deviation, perforation, ulcer of the nasal septum, thickening, pallor, edema, erosion of the nasal mucosa, hypertrophy and atrophy of the nasal wings, accumulation of fluid and pus in the nasal cavity, and space occupying or vegetation in the nasal cavity);
• Abnormal examination of the oropharynx has clinical significance, such as congestion, thickening, ulcers, hyperplasia or nodules, new organisms or foreign bodies of the throat mucosa;
• The following symptoms or diseases with clinical significance: a) a history of long-term nasal congestion, runny nose, headache, nosebleed, and other symptoms; b) Asthma, chronic respiratory diseases, etc; c) History of allergic rhinitis, chronic rhinitis, and sinusitis; d) History or signs of nasal, pharyngeal, and upper respiratory diseases that other researchers believe may affect the interpretation of the research process and/or local adverse events;
• Suffering from severe neurological disorders (epilepsy, seizures or convulsions) or mental illness, with a family history of mental illness, and neurological and psychiatric problems associated with various organic disorders;
• Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or coagulation disorders diagnosed by a doctor;
• Other uncontrolled chronic or severe disease history, including but not limited to cardiovascular disease, hematological system disease, liver and kidney disease, digestive system disease, respiratory system disease, malignant tumor, history of major organ transplantation, HIV/HBV/HCV/syphilis infection, or any other disease or physiological condition that the researcher believes can interfere with the test results;
• Planned pregnancy within 3 months, already pregnant (including positive pregnancy test), or breastfeeding;
• Received any SARS-CoV-2 neutralizing antibody injection that has been marketed or under research within 180 days prior to screening, or participated in clinical trials of other drugs or medical devices within 90 days prior to screening;
• Individuals who are unable to cooperate with nasal spray inhalation, nasal swab sampling, and venous blood collection, or who require long-term/intermittent use of any nasal products;
• Those with a body temperature above 37.0 ℃ before the first medication;
• weeks prior to screening for clinically significant acute or chronic disease exacerbations, or a history of surgery;
• Known to have a history of SARS-CoV-2 infection within 3 months;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Beijing Ditan Hospital Capital Medical University

Beijing, Chaoyang, 100015, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ronghua Jin, M.D.

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronghua Jin, M.D.

CONTACT

010-84323059; ronghuajin@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 21, 2023
• Study Start: May 31, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-05

Locations

CN (1)