COVID-19Phase 1NCT06050460
SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19
A Phase 1 study testing SA55 Injection in people with COVID-19, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial summary
In this first-in-humans dose escalation study, SA55 will be evaluated for safety, tolerability, and pharmacokinetics. The study is intended to enable future studies of SA55-injection's efficacy in preventing and treating COVID-19. 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 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 30 Dec 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 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 and their sexual partners did not have any family planning during the study period, voluntarily took effective contraceptive measures, and did not have plans to donate sperm or eggs; Or for surgical sterilization (female: bilateral fallopian tube ligation, bilateral ovariectomy or hysterectomy; male: vas deferens ligation or vas deferens blockage surgery);
- 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;
- The test results of hepatitis B B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antibody (HIV Ab) or Treponema pallidum antibody were positive;
- 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, or any other disease or physiological condition that the researcher believes can interfere with the test results;
- The target injection site (deltoid muscle of the upper arm) may interfere with drug administration or local reaction observation due to skin damage, inflammation, ulcers, rashes, and scars;
Show all 20Show fewer
- (Female subjects) who are pregnant (including those who have tested positive for pregnancy) or are breastfeeding;
- Have received any SARS-CoV-2 neutralizing antibody injection that is already on the market or in research before screening;
- Participated in clinical trials of other drugs or medical devices within 3 months prior to screening;
- Individuals with a body temperature greater than 37.0 ℃ on the day of medication (Day 1);
- 4 weeks prior to screening for clinically significant acute or chronic disease exacerbations, or a history of surgery;
- It is known that there is a history of SARS CoV-2 infection within 3 months (including positive detection of COVID-19 nucleic acid/antigen during enrollment and screening) or COVID-19 vaccine has been vaccinated;
- Blood donation>400 mL or significant blood loss>400 mL within 3 months prior to medication; Donate plasma or platelets within one month before medication;
- Within the first 6 months of screening, use of immunoglobulins or blood products, immune modulators such as corticosteroids and thymosin α Or blood stimulating drugs;
- 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;
- The weekly alcohol consumption in the three months before screening was more than 14 drinking units (1 drinking unit=14g 100% alcohol=360mL beer, or 150mL wine; or 45mL distilled wine/Baijiu), or alcohol abstinence was not allowed during the test, or alcohol breath test was positive before enrollment;
- Have a history of drug abuse or dependence or recreational drug use within 2 years prior to screening, or have 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, 100015
Ronghua Jin, 01084323059, ronghuajin@ccmu.edu.cn
Ronghua Jin, M.D.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of A Broad-Spectrum Neutralizing Antibodies SA55 Injection of COVID-19 in Healthy Adults
In this first-in-humans dose escalation study, SA55 will be evaluated for safety, tolerability, and pharmacokinetics. The study is intended to enable future studies of SA55-injection's efficacy in preventing and treating COVID-19.
Read the detailed description
This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study.
A Screening Period of up to 14 days (Day -14 through Day 0); A Treatment Period during which participants will be resident at the hospital from Day 0, 1 day before IMP administration (on Day 1) . A Follow up Period lasting 183 days after the IMP dose.
The study will be conducted at a single study centre in Beijing, China.
- Conditions
- COVID-19
- Being tested
- SA55 Injection, Placebo for SA55 injection
- 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 InjectionDrug
Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
Placebo for SA55 injectionOther
Placebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
| Study group | Role | What they receive |
|---|---|---|
| SA55 injection | Experimental | Cohort 1: 150mg; Cohort 2: 300mg; Cohort3: 600 mg; Cohort4: 900 mg Receives: Drug: SA55 Injection |
| Placebo for SA55 injection | Placebo comparator | Cohort 1: 0mg; Cohort 2: 0mg; Cohort3: 0mg; Cohort4: 0mg Receives: Other: Placebo for SA55 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with adverse events (AEs) and serious AEs in healthy individuals
The incidence of adverse events (including clinical symptoms and vital signs abnormalities, laboratory examination abnormalities, 12 lead electrocardiogram abnormalities, etc.) and serious adverse events;
Measured: 6 months
Secondary outcomes (7)
Time to reach maximum concentration (Tmax)
Tmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Measured: 6 months
Observed maximum concentration (Cmax)
Cmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Measured: 6 months
Elimination half life (t½)
t½ will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Measured: 6 months
Systemic clearance (CL)
CL will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Measured: 6 months
Volume of distribution (Vd)
Vd will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Measured: 6 months
AUCinf
AUCinf will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Measured: 6 moths
Anti drug antibody levels (ADA)
To evaluate the serum neutralizing activity of SA55 injection at different time points after administration in healthy individuals. It means anti drug antibody levels (ADA) in serum at different time points
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Jun 2023
- Primary completion30 Oct 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronghua Jin, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050460
- Sponsor's protocol ID
- PRO-SA55-1001
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Meng X, Li J, Zeng G, Wang J, Cao Y, Hu C, Jin R. Safety, tolerability, and pharmacokinetics of anti-SARS-CoV-2 monoclonal antibody SA55 injection in healthy participants. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0056825. doi: 10.1128/aac.00568-25. Epub 2025 Jul 17.
PubMed 40673766
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of A Broad-Spectrum Neutralizing Antibodies SA55 Injection of COVID-19 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06050460
- Acronym / sponsor ID
- PRO-SA55-1001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 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.
In this first-in-humans dose escalation study, SA55 will be evaluated for safety, tolerability, and pharmacokinetics. The study is intended to enable future studies of SA55-injection's efficacy in preventing and treating COVID-19.
Detailed description
This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study.
A Screening Period of up to 14 days (Day -14 through Day 0); A Treatment Period during which participants will be resident at the hospital from Day 0, 1 day before IMP administration (on Day 1) . A Follow up Period lasting 183 days after the IMP dose.
The study will be conducted at a single study centre in Beijing, China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SA55 injection | Experimental | Drug: SA55 InjectionCohort 1: 150mg; Cohort 2: 300mg; Cohort3: 600 mg; Cohort4: 900 mg |
| Placebo for SA55 injection | Placebo comparator | Other: Placebo for SA55 injectionCohort 1: 0mg; Cohort 2: 0mg; Cohort3: 0mg; Cohort4: 0mg |
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 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 and their sexual partners did not have any family planning during the study period, voluntarily took effective contraceptive measures, and did not have plans to donate sperm or eggs; Or for surgical sterilization (female: bilateral fallopian tube ligation, bilateral ovariectomy or hysterectomy; male: vas deferens ligation or vas deferens blockage surgery);
- 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 (20 listed)
- Individuals who are known to be allergic to the investigational drug, any component in the preparation, or other similar drugs;
- The test results of hepatitis B B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antibody (HIV Ab) or Treponema pallidum antibody were positive;
- 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, or any other disease or physiological condition that the researcher believes can interfere with the test results;
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 InjectionNovel coronavirus broad-spectrum neutralizing antibody SA55 injection | Drug | SA55 injection |
| Placebo for SA55 injectionPlacebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection | Other | Placebo for SA55 injection |
Primary outcome
Incidence of participants with adverse events (AEs) and serious AEs in healthy individuals
Time frame: 6 months
The incidence of adverse events (including clinical symptoms and vital signs abnormalities, laboratory examination abnormalities, 12 lead electrocardiogram abnormalities, etc.) and serious adverse events;
7 secondary outcomes
Time to reach maximum concentration (Tmax)
Time frame: 6 months
Observed maximum concentration (Cmax)
Time frame: 6 months
Elimination half life (t½)
Time frame: 6 months
Systemic clearance (CL)
Time frame: 6 months
Volume of distribution (Vd)
Time frame: 6 months
AUCinf
Time frame: 6 moths
Anti drug antibody levels (ADA)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 40673766Zhou Y, Meng X, Li J, Zeng G, Wang J, Cao Y, Hu C, Jin R. Safety, tolerability, and pharmacokinetics of anti-SARS-CoV-2 monoclonal antibody SA55 injection in healthy participants. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0056825. doi: 10.1128/aac.00568-25. Epub 2025 Jul 17.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 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 Injection 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 20 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 22 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 (01084323059, ronghuajin@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of participants with adverse events (AEs) and serious AEs in healthy individuals (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06050460, which also lists 1 linked publication.
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 22 Sep 2023.