Haemoglobin or platelet count below the LLN at screening.Aspartate aminotransferase, ALT, or serum creatinine above the ULN bilirubin and ALP >1.5 Г— ULN.History of infection with SARS or MERS.Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening.

HIV testing must be negative at screening.

Immunodeficiency due to illness, including Human immunodeficiency virus (HIV) infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.

Previous receipt of a mAb within 6 months, or five antibody half lives (whichever is longer), prior to study start.Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.Any prior receipt of investigational or licensed vaccine indicated for the prevention of SARS CoV-2 or COVID-19 or expected receipt during the period of study follow up.Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.Participants with any confirmed current or previous COVID-19 infection before randomisation.Receipt of immunoglobulin or blood products within 6 months prior to screening.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening.Vitamins and other nutritional supplements that are not newly introduced, ie, have been taken for at least 30 days prior to enrolment, are not exclusionary. Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine, or combination over the counter (OTC) product that contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory agent at a dose equal to or lower than that recommended on the package).Acute (time-limited) illness, including fever above 37.5вЊ (99.5 вЏ), on day prior to or day of planned dosing participants excluded for transient acute illness may be dosed if illness resolves within the 27-day Screening Period or may be rescreened once.Previous hypersensitivity, infusion-related reaction or severe adverse reaction following administration of a mAbs.History of allergic disease or reactions likely to be exacerbated by any component of the IMP.Known hypersensitivity to any component of the IMP.Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential who are sexually active with a non-sterilised male partner must have used a highly effective method of contraception for at least 28 days prior to dosing with IMP and must agree to continue using such precautions until the Final Follow-up Visit.Able to complete the Follow-up Period through Day 361.Electrocardiogram without clinically significant abnormalities at screening.Healthy by medical history, physical examination, and baseline safety laboratory studies, according to the judgement of the PI.Weight в‰Ґ 50 kg and в‰¤ 110 kg at screening, including a BMI of в‰Ґ 18.0 to в‰¤ 30.0 kg/m^2.Negative SARS-CoV-2 qRT-PCR and/or serology tests prior to randomisation.Written informed consent and any locally required authorisation obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.Why Should I Register and Submit Results?.

Phoenix winnonlin tutorial