Complicated InfectionPhase 1NCT01689207

To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)

A Phase 1 study testing Avibactam (AVI), Aztreonam (ATM) and combination of Aztreonam - Avibactam (ATM-AVI) in people with Complicated Infection and Bacterial Infections, run by Pfizer at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of ATM-AVI. The study aims to characterise the pharmacokinetics of ATM-AVI, when both drugs are administered alone (ATM or AVI) and in combination (ATM-AVI), following single administration, and following multiple… Read more about this study

Who is it for?: Ages 18 to 130 yearsHealthy volunteers can take part
Conditions the study is for: Complicated Infection, Bacterial Infections
What is being tested?: Avibactam (AVI), Aztreonam (ATM) and combination of Aztreonam - Avibactam (ATM-AVI)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 222 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2012to Dec 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 130 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or repeated venipuncture
Have a body mass index (BMI) between 19 and 30 kg/m2
Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the PI

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Known history of severe allergy to betalactam and/or L-arginine
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to ATM or AVI
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of IP

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam Given Alone and in Combination (ATM-AVI)

Read the detailed description

A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam given Alone and in Combination (ATM-AVI)

Conditions: Complicated Infection, Bacterial Infections
Being tested: Avibactam (AVI), Aztreonam (ATM), combination of Aztreonam - Avibactam (ATM-AVI), Placebo
Keywords: Phase I, Safety, tolerability, healthy.
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avibactam (AVI)Drug
PART A: AVI IV infusion
Aztreonam (ATM)Drug
PART A: ATM IV infusion
combination of Aztreonam - Avibactam (ATM-AVI)Drug
PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.
PlaceboDrug
PART A, PART B, PART C: matching placebo IV infusions

Study groups in NCT01689207
Study group	Role	What they receive
Drug: A	Experimental	Avibactam (AVI) Receives: Drug: Avibactam (AVI)
Drug: B	Experimental	Aztreonam (ATM) Receives: Drug: Aztreonam (ATM)
Drug: C	Experimental	combination of Aztreonam-Avibactam (ATM-AVI) Receives: Drug: combination of Aztreonam - Avibactam (ATM-AVI)
Drug: D	Placebo comparator	Matching Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Profile - Number of Subjects With at Least 1 AE
from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.
Measured: Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)

Secondary outcomes (6)

PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg*h/mL) or AUC(0-last) in Part A on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg*h/mL).
Measured: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion.
Measured: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C
Time to Cmax (tmax)
Measured: Day 1
PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion.
Measured: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Systemic clearence (CL) and renal clearance (CLr) on Day 1 after single infusion and at steady state after multiple infusion.
Measured: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Volume of distribution at steady state (Vss).
Measured: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Dec 2014

First posted21 Sep 2012 (estimated)
Study startSep 2012
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Complicated 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01689207
Sponsor's protocol ID: D4910C00001
Status last verified: Aug 2017
First submitted: 12 Sep 2012
Last updated: 6 Sep 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Das S, Riccobene T, Carrothers TJ, Wright JG, MacPherson M, Cristinacce A, McFadyen L, Xie R, Luckey A, Raber S. Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluation. Eur J Clin Pharmacol. 2024 Apr;80(4):529-543. doi: 10.1007/s00228-023-03609-x. Epub 2024 Jan 22.
PubMed 38252170

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
RecruitingPhase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
RecruitingPhase 3
Intravenous N-acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized With Influenza and Pneumonia
Influenza

All Complicated Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Double-blind, 3-Part Study in Healthy Young and Elderly Subjects to Assess the Safety and Tolerability, and Investigate the Pharmacokinetics of Aztreonam and Avibactam Given Alone and in Combination (ATM-AVI)
ClinicalTrials.gov ID: NCT01689207
Acronym / sponsor ID: D4910C00001
Conditions: Complicated Infection, Bacterial Infections
Keywords: Phase I, Safety, tolerability, healthy.
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 21 Sep 2012 (estimated)
Results: Posted 26 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Drug: A	Experimental	Drug: Avibactam (AVI)Avibactam (AVI)
Drug: B	Experimental	Drug: Aztreonam (ATM)Aztreonam (ATM)
Drug: C	Experimental	Drug: combination of Aztreonam - Avibactam (ATM-AVI)combination of Aztreonam-Avibactam (ATM-AVI)
Drug: D	Placebo comparator	Drug: PlaceboMatching Placebo

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or repeated venipuncture
Have a body mass index (BMI) between 19 and 30 kg/m2
Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the PI

Key exclusion criteria (5 listed)

History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Known history of severe allergy to betalactam and/or L-arginine
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to ATM or AVI
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of IP

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
Avibactam (AVI)PART A: AVI IV infusion	Drug	Drug: A
Aztreonam (ATM)PART A: ATM IV infusion	Drug	Drug: B
combination of Aztreonam - Avibactam (ATM-AVI)PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.	Drug	Drug: C
PlaceboPART A, PART B, PART C: matching placebo IV infusions	Drug	Drug: D

Primary outcome

Safety Profile - Number of Subjects With at Least 1 AE
Time frame: Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)
from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.

6 secondary outcomes

PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Time frame: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Time frame: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C
Time frame: Day 1
PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Time frame: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Time frame: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C
PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C
Time frame: 0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C

Results and safety

Results posted to the registry on 26 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Placebo	4	4
Part A: Drug	8	7
Part B: Placebo	16	16
Part B: Cohort 1 Drug	8	8
Part B: Cohort 2 Drug	4	2
Part B: Cohort 3 Drug	8	7
Part B: Cohort 4 Drug	10	10
Part B: Cohort 5 Drug	10	10
Part C: Placebo	6	5
Part C: Cohort 1 Drug	10	10
Part C: Cohort 2 Drug	8	8

Primary outcome: Safety Profile - Number of Subjects With at Least 1 AE

Time frame: Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C). Number. Unit: Participants

Measure	Part A: Placebo n = 4	Part A: Drug n = 8	Part B: Placebo n = 16	Part B: Cohort 1 Drug n = 8	Part B: Cohort 2 Drug n = 4	Part B: Cohort 3 Drug n = 8	Part B: Cohort 4 Drug n = 10	Part B: Cohort 5 Drug n = 10	Part C: Placebo n = 6	Part C: Cohort 1 Drug n = 10	Part C: Cohort 2 Drug n = 8	Part A: Avibactam (AVI) 600mg n = 8
Number of subjects with at least 1 AE	1	2	3	4	2	6	8	3	3	5	7	2
Subjects with at least 1 AE with outcome of death	0	0	0	0	0	0	0	0	0	0	0	0
At least 1 AE leading to discontinuation	0	1	0	0	2	1	0	0	1	0	0	1

Population analysed: Safety population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: from screening visit (Day -28) to follow up visit (FUP).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Placebo	0 of 4 (0%)	1 of 4 (25%)	Not reported
Part A: Drug	0 of 8 (0%)	2 of 8 (25%)	Not reported
Part B: Placebo	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
Part B: Cohort 1 Drug	0 of 8 (0%)	4 of 8 (50%)	Not reported
Part B: Cohort 2 Drug	0 of 4 (0%)	2 of 4 (50%)	Not reported
Part B: Cohort 3 Drug	0 of 8 (0%)	6 of 8 (75%)	Not reported
Part B: Cohort 4 Drug	0 of 10 (0%)	8 of 10 (80%)	Not reported
Part B: Cohort 5 Drug	0 of 10 (0%)	3 of 10 (30%)	Not reported
Part C: Placebo	1 of 6 (16.7%)	3 of 6 (50%)	Not reported
Part C: Cohort 1 Drug	0 of 10 (0%)	5 of 10 (50%)	Not reported
Part C: Cohort 2 Drug	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Part A: Aztreonam (ATM) 2000mg	0 of 7 (0%)	0 of 7 (0%)	Not reported
Part A: Avibactam (AVI) 600mg	0 of 8 (0%)	2 of 8 (25%)	Not reported
Part A: ATM 2000mg + AVI 600mg	0 of 7 (0%)	0 of 7 (0%)	Not reported

Limitations and caveats (from the sponsor): No formal statistical hypothesis testing was performed. The analyses of safety, tolerability, and pharmacokinetic data were summarised descriptively including tables, listings, and graphs, as appropriate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38252170Das S, Riccobene T, Carrothers TJ, Wright JG, MacPherson M, Cristinacce A, McFadyen L, Xie R, Luckey A, Raber S. Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluation. Eur J Clin Pharmacol. 2024 Apr;80(4):529-543. doi: 10.1007/s00228-023-03609-x. Epub 2024 Jan 22.

Related trials for Complicated Infection

RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
RecruitingPhase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
RecruitingPhase 3
Intravenous N-acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized With Influenza and Pneumonia
Influenza

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.

Frans van den Berg, MD principal investigator

Hammersmith Medicines Research Cumberland Avenue Park Royal London NW10 7EW, England Telephone: +44 020 8961 4130 Fax: +44 020 8961 8665

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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 6 Sep 2017. 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 United Kingdom. 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?

Yes. Results are posted in the registry (first posted 26 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety Profile - Number of Subjects With at Least 1 AE (time frame: Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01689207, which also lists 1 linked publication.

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 6 Sep 2017.