Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects
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|ClinicalTrials.gov Identifier: NCT04483375|
Recruitment Status : Completed
First Posted : July 23, 2020
Last Update Posted : March 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Disease 2019(COVID-19)||Biological: SCTA01 Other: Placebo||Phase 1|
This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.
Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse events (AEs), and laboratory results of the prior dose cohort.
An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for review.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects|
|Actual Study Start Date :||July 24, 2020|
|Actual Primary Completion Date :||November 17, 2020|
|Actual Study Completion Date :||November 17, 2020|
Experimental: anti-SARS-CoV-2 monoclonal antibody(SCTA01)
SCTA01: single dose on Day0
recombinant humanized anti-SARS-CoV-2 monoclonal antibody
Placebo Comparator: Placebo
Placebo: single dose on Day0
- Dose-limiting toxicity(DLT) [ Time Frame: 7 days ]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
- Maximal Tolerable Dose(MTD) [ Time Frame: 12 weeks ]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.
- AUC0-t [ Time Frame: 12 weeks ]Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t)
- AUC0-∞ [ Time Frame: 12 weeks ]Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞)
- t1/2 [ Time Frame: 12 weeks ]Elimination Phase Half-life(t1/2)
- Tmax [ Time Frame: 12 weeks ]Time to the Maximum Concentration(Tmax)
- Anti-drug antibody(ADA) [ Time Frame: 12 weeks ]Positive rate of anti-SCT A01 antibody
- Adverse events [ Time Frame: 12 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483375
|Beijing SHIJITAN Hospital|
|Beijing, Beijing, China, 100038|
|Principal Investigator:||Xinghe Wang, MD,PhD||Beijing Shijitan Hospital, Capital Medical University|