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
About this trial
This is an interventional treatment trial for Gram-negative Bacterial Infection focused on measuring Gram negative, bacteria, infection
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
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
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
Learn more about this trial
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
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