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

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

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.

Study Overview

• Status: Completed
• Conditions: Gram-negative Bacterial Infection
• Intervention / Treatment: Drug: AN3365; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • CMAX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2009
• Primary Completion (Actual): May 13, 2010
• Study Completion (Actual): May 13, 2010

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: November 16, 2009
• First Posted (Estimate): November 17, 2009

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: infection; bacteria; Gram negative
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections; Gram-Negative Bacterial Infections
• Other Study ID Numbers: AN3365-PK-101; C3501001 (Other Identifier: Alias Study Number)