Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects

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

Detailed Description
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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.

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

Conditions
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Coronavirus Disease 2019(COVID-19)

Intervention / Treatment
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* Biological: SCTA01
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent Males or females. Aged ≥ 18 years old Body mass index (BMI) between 18.0 and 26.0 kg/m2 Normal or abnormal but non-clinical significant physical examination, vital signs, 12-ECG and chest CT, etc No plan of pregnancy and being willing to use effective contraceptive measures (including partner) from informed consent to 6 months after administration of SCTA01/placebo (abstinence，sterilization operation，contraceptive barrier，acyeterion , etc.) Exclusion Criteria: Having a history of severe allergy, such as severe allergic reactions, urticaria, angioedema; Having one of the following evidence on SARS-CoV-2 infection(previous tests were accepted)： SARS-CoV-2 positive: reverse transcription-polymerase chain reaction (RT-PCR) and/or next generation sequencing (NGS) Previous viral gene sequencing showed high homology with the known SARS-CoV-2 Positive specific antibody IgM or IgG against serum SARS-CoV-2 Having a history of severe allergies, such as severe allergic reactions, urticaria, angioedema; Having active infection or fever before to enrollment(≥ 37.3℃) Having primary disease in main organs, such as heart, lung, kidney, liver, nervous system, gastrointestinal system dysfunction, history of thrombocytopenia or abnormal bleeding Suffering from autoimmune diseases or a history of autoimmune diseases (such as systemic lupus erythematosus, thyroid Inflammation, vasculitis, etc.) Within 7 days prior to the first dose of SCTA01/placebo, subject has received any prescription drugs, non-prescription drugs, Chinese herbal medicines and health products Within 3 months prior to the first dose of SCTA01/placebo, subjects who participated in other clinical study, or remaining in the elimination period of the drug (within 5 half-lives) before treatment Within 30 days prior to the first dose of SCTA01/placebo, subjects who have received vaccine Within 3 months prior to the first dose of SCTA01/placebo, subjects who have received blood product treatment or blood donation and hemorrhage ≥400mL, or subjects who has a blood donation plan within 3 months after treatment Within 6 months prior to the first dose of SCTA01/placebo, subjects who have received major surgery, or has surgery plan during clinical trail Pregnant or lactating women or positive β-HCG, has plan of pregnancy from informed consent signed to 6 months after administration of SCTA01/placebo Positive of anti-HIV, TP-Ab, anti-HCV, anti-HBV Having a history of epilepsy Having a history of malignancies Within 3 months prior to screening, sujects who have drunk more than 14 standard units (1 standard unit contains 14g alcohol, such as 360mL beer, 45mL spirits with 40% alcohol or 150mL wine), or positive of alcohol breath test Within 3 months prior to screening, subjects who smoked more than 5 cigarettes per day, do not accept smoking cessation during the study Having a history of drug addiction and drug abuse; or who have a positive urine test result for drug abuse; or cannot guarantee that they will not abuse drugs during the study Subjects who are not able to follow the plan to complete the study Subjects who are not considered suitable for the study by investigators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-SARS-CoV-2 monoclonal antibody(SCTA01)<br>SCTA01: single dose on Day0 | Biological: SCTA01<br>* recombinant humanized anti-SARS-CoV-2 monoclonal antibody<br>|
| Placebo Comparator: Placebo<br>Placebo: single dose on Day0 | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity(DLT) | 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 | 7 days | 
| Maximal Tolerable Dose(MTD) | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-t) | 12 weeks | 
| AUC0-∞ | Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) | 12 weeks | 
| t1/2 | Elimination Phase Half-life(t1/2) | 12 weeks | 
| Tmax | Time to the Maximum Concentration(Tmax) | 12 weeks | 
| Anti-drug antibody(ADA) | Positive rate of anti-SCT A01 antibody | 12 weeks | 
| Adverse events | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19