Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers

Exclusion Criteria

• •History of previous allergy or sensitivity to amikacin or fosfomycin.
• •Use of oral fosfomycin in the 28 days prior to admission to Phase 1 facility.
• •History of reactive airways disease (such as asthma or chronic obstructive pulmonary disease \[COPD\]), cystic fibrosis, or bronchiectasis.
• •Human Immunodeficiency Virus (HIV) positive.
• •Active Hepatitis B or C.
• •Cigarette/e-Cigarette smoking or use of other nicotine or tobacco containing products within seven days prior to study drug administration.
• •Positive for drugs of abuse or alcohol use at screening or admission to Phase 1 facility. A Breathalyzer test will be used to screen for the presence of alcohol. A urine standard panel will be used to test for the following substances (with serum testing for confirmation, as needed):
• •* Opiates
• •* Oxycodone
• •* Methadone
• •* Cocaine
• •* Tetrahydrocannabinol (THC)
• •* Benzodiazepines
• •* Amphetamines / Methamphetamines
• •* Barbiturates
• •* Methylenedioxy-methamphetamine (MDMA)
• •* Phenylcyclohexyl piperidine (PCP)
• •* Tricyclic Antidepressants
• •Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product.
• •Donation of blood or significant blood loss within the 8 weeks prior to admission to Phase 1 facility.
• •Donation of plasma within the week prior to admission to Phase 1 facility.
• •Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
• •Pregnant or nursing.