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

• ClinicalTrials.gov Identifier: NCT06050460
• Recruitment Status: Recruiting
• First Posted: September 22, 2023
• Last Update Posted: September 22, 2023
• Sponsor: Sinovac Life Sciences Co., Ltd.
• Information provided by (Responsible Party): Sinovac Biotech Co., Ltd ( Sinovac Life Sciences Co., Ltd. )

Tracking Information

• First Submitted Date: August 26, 2023
• First Posted Date: September 22, 2023
• Last Update Posted Date: September 22, 2023
• Actual Study Start Date: June 15, 2023
• Estimated Primary Completion Date: October 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2023)

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;

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 20, 2023)

• Time to reach maximum concentration (Tmax) [ Time Frame: 6 months ]
  Tmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
• Observed maximum concentration (Cmax) [ Time Frame: 6 months ]
  Cmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
• Elimination half life (t½) [ Time Frame: 6 months ]
  t½ will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
• Systemic clearance (CL) [ Time Frame: 6 months ]
  CL will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
• Volume of distribution (Vd) [ Time Frame: 6 months ]
  Vd will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
• AUCinf [ Time Frame: 6 moths ]
  AUCinf will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
• Anti drug antibody levels (ADA) [ Time Frame: 6 months ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
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.

Primary Purpose: Treatment

• Condition: COVID-19

Intervention

• Drug: SA55 Injection
  Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
• Other: Placebo for SA55 injection
  Placebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection

Study Arms

• Experimental: SA55 injection
  Cohort 1: 150mg; Cohort 2: 300mg; Cohort3: 600 mg; Cohort4: 900 mg
  Intervention: Drug: SA55 Injection
• Placebo Comparator: Placebo for SA55 injection
  Cohort 1: 0mg; Cohort 2: 0mg; Cohort3: 0mg; Cohort4: 0mg
  Intervention: Other: Placebo for SA55 injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 20, 2023): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2023
• Estimated Primary Completion Date: October 30, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ronghua Jin; 01084323059; ronghuajin@ccmu.edu.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06050460
• Other Study ID Numbers: PRO-SA55-1001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sinovac Biotech Co., Ltd ( Sinovac Life Sciences Co., Ltd. )
• Original Responsible Party: Same as current
• Current Study Sponsor: Sinovac Life Sciences Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ronghua Jin; Beijing Ditan Hospital

• PRS Account: Sinovac Biotech Co., Ltd
• Verification Date: September 2023