The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(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.
Biological: SCTA01
recombinant humanized anti-SARS-CoV-2 monoclonal antibody
Other: Placebo
Placebo
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
Beijing SHIJITAN Hospital
Beijing, Beijing, China
Xinghe Wang, MD,PhD, Principal Investigator
Beijing Shijitan Hospital, Capital Medical University