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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.

Detailed Description
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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.

Official Title
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First-in-human, Two-stage, Randomized, Placebo-controlled, Double-blind, Dose Escalation Study To Determine The Safety, Tolerability, And Pharmacokinetic Profile Of An3365 In Single And Multiple Doses In Young Healthy Subjects

Conditions
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Gram-negative Bacterial Infection

Intervention / Treatment
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* Drug: AN3365
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AN3365<br> | Drug: AN3365<br>* LP, 600 mg vial; reconstituted in Normal Saline<br>|
| Placebo Comparator: Saline<br> | Drug: Placebo<br>* 0.9% sodium chloride for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate) |  | Multiple time points up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality |  | Multiple time points up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gram negative, bacteria, infection