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SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19 | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

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

NCT06050460•Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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);
+10 more criteria

Locations (1)

Beijing Ditan Hospital Capital Medical University

Beijing, China

Key Dates

Start Date

June 15, 2023

Primary Completion Date

October 30, 2023

Completion Date

December 30, 2023

Last Updated

September 22, 2023

Enrollment

ESTIMATED participants

Conditions

COVID-19

Interventions

SA55 Injection

DRUG

Placebo for SA55 injection

OTHER

Contacts

Ronghua Jin

CONTACT

01084323059 ronghuajin@ccmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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