Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

Exclusion Criteria

• •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• •History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
• •Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
• •History of seizures (e.g., epilepsy).
• •Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
• •Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
• •Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).