Clinical trial NCT01015014: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gram-negative Bacterial Infection
Keywords: Gram negative
bacteria
infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
timeFrame: Multiple time points up to 14 days
Secondary outcomes:
measure: Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
timeFrame: Multiple time points up to 14 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: