Gram-negative Bacterial InfectionPhase 1NCT01015014
Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections
A Phase 1 study testing AN3365 in people with Gram-negative Bacterial Infection, run by Pfizer at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gram-negative Bacterial Infection
- What is being tested?
- AN3365
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Nov 2009to 13 May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gram-negative Bacterial Infection
- Being tested
- AN3365, Placebo
- Keywords
- Gram negative, bacteria, infection
- Medical subject headings
- Gram-Negative Bacterial Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN3365Drug
LP, 600 mg vial; reconstituted in Normal Saline
PlaceboDrug
0.9% sodium chloride for injection
| Study group | Role | What they receive |
|---|---|---|
| AN3365 | Active comparator | Not described Receives: Drug: AN3365 |
| Saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Multiple time points up to 14 days
Secondary outcomes (1)
Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
Measured: Multiple time points up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study start5 Nov 2009
- Primary completion13 May 2010
- Study completion13 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-negative Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015014
- Sponsor's protocol ID
- AN3365-PK-101
- Other IDs
- C3501001
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2009
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01015014
- Acronym / sponsor ID
- AN3365-PK-101
- Conditions
- Gram-negative Bacterial Infection
- Keywords
- Gram negative, bacteria, infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2009 (actual)
- Primary completion
- 13 May 2010 (actual)
- Study completion
- 13 May 2010 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AN3365 | Active comparator | Drug: AN3365 |
| Saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN3365LP, 600 mg vial; reconstituted in Normal Saline | Drug | AN3365 |
| Placebo0.9% sodium chloride for injection | Drug | Saline |
Primary outcome
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
1 secondary outcome
Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality
Time frame: Multiple time points up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AN3365 in people with Gram-negative Bacterial Infection, run by Pfizer at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Multiple time points up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.