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

Inclusion Criteria: * Males or females aged ≥18 years and ≤ 80 years of age (Cohorts 1, 2, 3, and 4). Males or females aged ≥ 18 years and ≤ 65 years of age (Cohort 5). * Females of childbearing potential must be using contraception. Acceptable methods of contraception include male or female condom with spermicide gel or foam, hormonal contraceptive combined with a condom, Intrauterine Device (IUD), tubal ligation, diaphragm with spermicide, or total abstinence with a back-up if the subject becomes active. * Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form. 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.