COVID-19Phase 1NCT06048393
SA55 Novel Coronavirus Broad-spectrum Neutralizing Antibody Nasal Spray in Health People
A Phase 1 study testing SA55 nasal spray in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- SA55 nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 31 Oct 2023
- Phase
- Phase 1
- 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
- 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.
Who cannot join
- 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;
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- 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;
- 4 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;
- Within 90 days before the first medication, blood donation>400 mL or significant blood loss>400 mL; Or donate plasma within 30 days before the first medication;
- Within 180 days prior to screening, use of immunoglobulins or blood products, immune modulators (such as adrenocortical hormones and thymosin) α Or blood stimulating drugs;
- Have been inoculated with any marketed or under research COVID-19 nasal spray vaccine within 180 days before screening, or have been inoculated with any marketed or under research COVID-19 vaccine within 90 days;
- Received attenuated live vaccine within 14 days prior to screening, or received subunit or inactivated vaccine within 7 days;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and functional vitamins within the first 14 days of screening;
- Smokers who smoke ≥ 5 cigarettes per day within the first 3 months of screening, or who cannot guarantee giving up smoking during the trial period;
- Drinking more than 14 units (1 unit of alcohol is equivalent to 360 mL of beer, 150 mL of wine, or 45 mL of Baijiu) per week within 3 months before screening, or not abstaining from alcohol during the test, or having a history of alcohol abuse within 2 years, or positive alcohol breath test before enrollment;
- There is a history of drug abuse or dependence or recreational drug use within 2 years prior to screening, or a positive urine drug abuse screening before enrollment.
- According to the judgment of the researchers, the subjects have any other factors that are not suitable for participating in clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing, Chaoyang, 100015
Ronghua Jin, M.D., 010-84323059, ronghuajin@ccmu.edu.cn
Ronghua Jin, M.D.
About this study
Official title: A Phase I Clinical Study of Novel Coronavirus Broad-spectrum Neutralizing Antibody SA55 Nasal Spray in Healthy People
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
- Being tested
- SA55 nasal spray
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA55 nasal sprayDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SA55 nasal spray |
| Group2 | Placebo comparator | Single-dose: 1 spray per side per time Multi-dose: 2 sprays per side per time Receives: Drug: SA55 nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of SA55 nasal spray
The incidence and types of adverse events during the study period
Measured: 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
The local drug content in the nasal cavity at different time points after single and multiple administration
Measured: 1 month
To evaluate the systemic exposure level of SA55 nasal spray after single and multiple administration
Concentration of SA55 in serum at different time points after medication
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 May 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronghua Jin, M.D., Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048393
- Sponsor's protocol ID
- PRO-SA55-1002
- Status last verified
- May 2023
- First submitted
- 26 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of Novel Coronavirus Broad-spectrum Neutralizing Antibody SA55 Nasal Spray in Healthy People
- ClinicalTrials.gov ID
- NCT06048393
- Acronym / sponsor ID
- PRO-SA55-1002
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 21 Sep 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: SA55 nasal spraySingle-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 |
| Group2 | Placebo comparator | Drug: SA55 nasal spraySingle-dose: 1 spray per side per time Multi-dose: 2 sprays per side per time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
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 |
|---|---|---|
| SA55 nasal sprayThe 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. | Drug | Group1, Group2 |
Primary outcome
To evaluate the safety and tolerability of SA55 nasal spray
Time frame: 1 month
The incidence and types of adverse events during the study period
2 secondary outcomes
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
Time frame: 1 month
To evaluate the systemic exposure level of SA55 nasal spray after single and multiple administration
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ronghua Jin, M.D. principal investigator
Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SA55 nasal spray in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. 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 5 inclusion and 24 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 21 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ronghua Jin, M.D. (010-84323059, ronghuajin@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of SA55 nasal spray (time frame: 1 month). 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 21 Sep 2023.