SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19 (NCT06050460) | Clinical Trial Compass
UnknownPhase 1
SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19
China40 participantsStarted 2023-06-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 abnorma…
What they're measuring
1
Incidence of participants with adverse events (AEs) and serious AEs in healthy individuals