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 37.5☌ (99.5 ☏), 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 ≥ 50 kg and ≤ 110 kg at screening, including a BMI of ≥ 18.0 to ≤ 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.
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