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SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SA55 Injection
Placebo for SA55 injection
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; (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.

Sites / Locations

  • Beijing Ditan Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SA55 injection

Placebo for SA55 injection

Arm Description

Cohort 1: 150mg; Cohort 2: 300mg; Cohort3: 600 mg; Cohort4: 900 mg

Cohort 1: 0mg; Cohort 2: 0mg; Cohort3: 0mg; Cohort4: 0mg

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

Time to reach maximum concentration (Tmax)
Tmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Observed maximum concentration (Cmax)
Cmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Elimination half life (t½)
t½ will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Systemic clearance (CL)
CL will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Volume of distribution (Vd)
Vd will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
AUCinf
AUCinf will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
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

Full Information

First Posted
August 26, 2023
Last Updated
September 20, 2023
Sponsor
Sinovac Life Sciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06050460
Brief Title
SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
The study will be blinded for all placebo controlled dose groups, ie, the principal investigator (PI), all clinical staff involved in the clinical study, the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SA55 injection
Arm Type
Experimental
Arm Description
Cohort 1: 150mg; Cohort 2: 300mg; Cohort3: 600 mg; Cohort4: 900 mg
Arm Title
Placebo for SA55 injection
Arm Type
Placebo Comparator
Arm Description
Cohort 1: 0mg; Cohort 2: 0mg; Cohort3: 0mg; Cohort4: 0mg
Intervention Type
Drug
Intervention Name(s)
SA55 Injection
Intervention Description
Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
Intervention Type
Other
Intervention Name(s)
Placebo for SA55 injection
Intervention Description
Placebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
Primary Outcome Measure Information:
Title
Incidence of participants with adverse events (AEs) and serious AEs in healthy individuals
Description
The incidence of adverse events (including clinical symptoms and vital signs abnormalities, laboratory examination abnormalities, 12 lead electrocardiogram abnormalities, etc.) and serious adverse events;
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to reach maximum concentration (Tmax)
Description
Tmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time Frame
6 months
Title
Observed maximum concentration (Cmax)
Description
Cmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time Frame
6 months
Title
Elimination half life (t½)
Description
t½ will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time Frame
6 months
Title
Systemic clearance (CL)
Description
CL will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time Frame
6 months
Title
Volume of distribution (Vd)
Description
Vd will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time Frame
6 months
Title
AUCinf
Description
AUCinf will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time Frame
6 moths
Title
Anti drug antibody levels (ADA)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronghua Jin
Phone
01084323059
Email
ronghuajin@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronghua Jin
Organizational Affiliation
Beijing Ditan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronghua Jin
Phone
01084323059
Email
ronghuajin@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Ronghua Jin, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19

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