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

Primary Purpose

Gram-negative Bacterial Infection

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AN3365
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-negative Bacterial Infection focused on measuring Gram negative, bacteria, infection

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CMAX

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AN3365

Saline

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality

Full Information

First Posted
October 20, 2009
Last Updated
March 4, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01015014
Brief Title
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2009 (Actual)
Primary Completion Date
May 13, 2010 (Actual)
Study Completion Date
May 13, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-negative Bacterial Infection
Keywords
Gram negative, bacteria, infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AN3365
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AN3365
Intervention Description
LP, 600 mg vial; reconstituted in Normal Saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride for injection
Primary Outcome Measure Information:
Title
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)
Time Frame
Multiple time points up to 14 days
Secondary Outcome Measure Information:
Title
Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
Time Frame
Multiple time points up to 14 days

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
CMAX
City
Adelaide
Country
Australia

12. IPD Sharing Statement

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

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