Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections

Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.

Inclusion criteria

• Young healthy males, 18-45 years (inclusive) of age
• Healthy as judged by a responsible physician with no clinically significant abnormality
• Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during sexual intercourse with a female partner who uses another form of contraception
• Body weight above 50 kg (Body Mass Index between 19 and 30 kg/m2)
• Non-smokers
• Willing and able to comply with study instructions and commit to all follow-up visits
• Ability to understand, agree to and sign the study Informed Consent Form (ICF)

Exclusion criteria

• History of serious adverse reactions or hypersensitivity to any drug; or who have a known allergy to any of the test product(s) or any components in the test product(s); or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
• Any clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions
• Abnormal physical findings of clinical significance at the screening examination or baseline
• History of orthostatic hypotension
• Clinically significant abnormal laboratory values
• Presence or history of allergies requiring acute or chronic treatment
• 12 lead ECG abnormalities
• Major surgical interventions within 6 months of the study
• Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result
• Use of prescription or non-prescription drugs
• Has a history of regular alcohol consumption
• Loss of 500 mL blood or more during the 3 month period before the study
• People that follow vegetarian or vegan diet
• Symptoms of a significant somatic or mental illness in the four week period preceding drug administration
• History of drug abuse or dependence within 12 months of the study
• The subject has a positive pre-study alcohol or urine drug screen
• Concurrent participation in another drug or device research study or within 60 days of post participation in another drug or device study
• Considered by the Investigator to be unsuitable candidate for this study