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

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.

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