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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01015014




Registration number
NCT01015014
Ethics application status
Date submitted
20/10/2009
Date registered
17/11/2009
Date last updated
5/03/2019

Titles & IDs
Public title
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
Scientific 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
Secondary ID [1] 0 0
C3501001
Secondary ID [2] 0 0
AN3365-PK-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gram-negative Bacterial Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AN3365
Treatment: Drugs - Placebo

Active Comparator: AN3365 -

Placebo Comparator: Saline -


Treatment: Drugs: AN3365
LP, 600 mg vial; reconstituted in Normal Saline

Treatment: Drugs: Placebo
0.9% sodium chloride for injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Multiple time points up to 14 days
Secondary outcome [1] 0 0
Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
Timepoint [1] 0 0
Multiple time points up to 14 days

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2010
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01015014
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01015014