CovidResearchTrials by Shray Alag


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SCTA01Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug3293 hyperbaric oxygen therapy (HBOT) Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.

NCT04483375 Coronavirus Disease 2019(COVID-19) Biological: SCTA01 Other: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Description: DLT will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs

Measure: Dose-limiting toxicity(DLT)

Time: 7 days

Description: MTD will be assessed by DAIDS v2.1. The measurements include clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs.

Measure: Maximal Tolerable Dose(MTD)

Time: 12 weeks

Secondary Outcomes

Description: Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)

Measure: AUC0-t

Time: 12 weeks

Description: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)

Measure: AUC0-∞

Time: 12 weeks

Description: Elimination Phase Half-life(t1/2)

Measure: t1/2

Time: 12 weeks

Description: Time to the Maximum Concentration(Tmax)

Measure: Tmax

Time: 12 weeks

Description: Positive rate of anti-SCT A01 antibody

Measure: Anti-drug antibody(ADA)

Time: 12 weeks

Description: Adverse events as assessed by DAIDS v2.1, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs

Measure: Adverse events

Time: 12 weeks


No related HPO nodes (Using clinical trials)