Study of the Safety of USB005 in Healthy Volunteers

Inclusion criteria

• . Healthy male or female volunteers, aged 18-64 years (inclusive) at the time of signing the ICF;
• . For females:
• . Surgically sterilized (eg, hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening and menopause will be confirmed by a plasma FSH level of \>40 IU/L) or
• . Women of childbearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control (e.g., established hormonal birth control plus a barrier method, double barrier method: intrauterine device plus condom or spermicidal gel plus condom) from 21 days prior to dosing until 7 days after dosing, and
• . Women with a negative pregnancy test (β-hCG assay) at screening and Day -1;
• . Weight of 45-100 kg and BMI of 17.5-35 kg/m2 (inclusive);
• . Blood pressure no greater than 120/80 mm Hg (inclusive);
• . Healthy, as determined by medical history, physical examination, vital signs, and clinical laboratory tests, unless the Investigator considers an abnormality to be clinically irrelevant;

Exclusion criteria