HealthyPhase 1NCT04973826

Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.

A Phase 1 study testing Aztreonam-Avibactam in people with Healthy, run by Pfizer at 1 site in China.

Completed

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

Trial summary

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Aztreonam-Avibactam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 20 Aug 2021to 27 Sep 2021
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Chinese male and female participants
No clinical relevant abnormalities
willing and able to comply with all study procedures
BMI:17.5-30.5
Sign informed consent

Who cannot join

Any clinical significant illness
History of alcohol abuse
Use within 14 days prior the first study dose
CL>80ml/min
Abnormal vital signs, such 12-ECG, blood pressure and pulse rate
Blood donation within 60days
History of HIV, HBsAg, HBcAb, HCVAb
Other medical or psychiatric may inappropriate for the study

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 201107

Other trials in China

About this study

Official title: A PHASE I, SINGLE CENTER, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM ADMINISTERED AS SINGLE AND REPEATED INTRAVENOUS DOSES IN HEALTHY CHINESE PARTICIPANTS

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.

Conditions: Healthy
Being tested: Aztreonam-Avibactam
Keywords: no clinically relevant abnormalities

What participants receive

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

Aztreonam-AvibactamDrug
500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours

Study groups in NCT04973826
Study group	Role	What they receive
ATM-AVI treatment arm	Experimental	Chinese healthy volunteers Receives: Drug: Aztreonam-Avibactam

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1
Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Aztreonam
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Avibactam
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Aztreonam
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Avibactam
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Aztreonam
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Avibactam
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Aztreonam
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Avibactam
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Aztreonam
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Avibactam
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Renal Clearance (CLr) on Day 1 & 4 of Aztreonam
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Renal Clearance (CLr) on Day 1 & 4 of Avibactam
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4

Secondary outcomes (18)

Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Aztreonam
Plasma terminal elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by one half at the terminal phase.
Measured: Post dose on day 1 and day 4
Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Avibactam
Plasma terminal elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by one half at the terminal phase.
Measured: Post dose on day 1 and day 4
Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Aztreonam
Apparent volume of distribution (Vz) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss was the Vz at steady-state. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Avibactam
Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss was the Vz at steady-state. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Aztreonam
Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Avibactam
Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Clearance (CL) on Day 1 & 4 of Aztreonam
CL was a quantitative measure of the rate at which a drug substance was removed from the body. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Clearance (CL) on Day 1 & 4 of Avibactam
CL was a quantitative measure of the rate at which a drug substance was removed from the body. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 1 and day 4
Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Aztreonam
Tmax was defined as time to reach maximum observed plasma concentration.
Measured: Post dose on day 1 and day 4
Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Avibactam
Tmax was defined as time to reach maximum observed plasma concentration.
Measured: Post dose on day 1 and day 4
Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Aztreonam
Accumulation ratio based on maximum plasma concentration (Rac,cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 4) divided by Cmax at first dose (Day 1). The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Avibactam
Accumulation ratio based on maximum plasma concentration (Rac,cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 4) divided by Cmax at first dose (Day 1). The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Aztreonam
Rac was obtained from AUCtau at steady state (Day 4) divided by AUCtau after single dose (Day 1). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Avibactam
Rac was obtained from AUCtau at steady state (Day 4) divided by AUCtau after single dose (Day 1). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Measured: Post dose on day 4
Number of Participants With an Adverse Event (AE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason. Symptoms of infusion-related reactions (IRRs) may include, but were not limited to, fever, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Measured: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Number of Participants With Abnormal Vital Signs
Criteria for vital signs abnormalities: increase or decrease from baseline in supine Systolic Blood Pressure (SBP) >=30 mm Hg and increase or decrease from baseline in supine Diastolic Blood Pressure (DBP) >=20 mm Hg.
Measured: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Number of Participants With Abnormal Electrocardiograms (ECGs)
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.
1. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.
2. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline.
Measured: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Number of Participants With Abnormal Laboratory Assessments
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (basophils); clinical chemistry (urate); urinalysis (urine hemoglobin, nitrite, urine erythrocytes).
Measured: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)

Timeline

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

20 Aug 202127 Sep 2021

First posted22 Jul 2021
Study start20 Aug 2021
Primary completion27 Sep 2021
Study completion27 Sep 2021

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 HealthyStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04973826
Sponsor's protocol ID: C3601007
Status last verified: Sep 2022
First submitted: 13 Jul 2021
Last updated: 28 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Wang J, He J, Wu J, Zhang J, Ma Y, Ren X, Wei H, Zhang C, Zhu H, Raber SR, Cong S. Pharmacokinetics of Aztreonam-Avibactam After Single- and Multiple-Dose Administration: A Phase 1, Open-Label Study in Healthy Chinese Participants and Ethnic Comparison with Non-Chinese Participants. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e70040. doi: 10.1002/cpdd.70040.
PubMed 41709845

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE I, SINGLE CENTER, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM ADMINISTERED AS SINGLE AND REPEATED INTRAVENOUS DOSES IN HEALTHY CHINESE PARTICIPANTS
ClinicalTrials.gov ID: NCT04973826
Acronym / sponsor ID: C3601007
Conditions: Healthy
Keywords: no clinically relevant abnormalities
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 Aug 2021 (actual)
Primary completion: 27 Sep 2021 (actual)
Study completion: 27 Sep 2021 (actual)
First posted: 22 Jul 2021 (actual)
Results: Posted 28 Jul 2023

Clinical summary

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

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ATM-AVI treatment arm	Experimental	Drug: Aztreonam-AvibactamChinese healthy volunteers

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy Chinese male and female participants
No clinical relevant abnormalities
willing and able to comply with all study procedures
BMI:17.5-30.5
Sign informed consent

Key exclusion criteria (8 listed)

Any clinical significant illness
History of alcohol abuse
Use within 14 days prior the first study dose
CL>80ml/min
Abnormal vital signs, such 12-ECG, blood pressure and pulse rate

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
Aztreonam-Avibactam500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours	Drug	ATM-AVI treatment arm

Primary outcome

Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.
Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric Mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam
Time frame: Post dose on day 1
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam
Time frame: Post dose on day 1
The area under the plasma drug concentration-time curve (AUC) was estimated from time 0 to 6 hours post dose. AUC6 was computed using the Linear/Log trapezoidal method. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Aztreonam
Time frame: Post dose on day 4
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Avibactam
Time frame: Post dose on day 4
AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Aztreonam
Time frame: Post dose on day 4
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage.
Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Avibactam
Time frame: Post dose on day 4
AUC24,ss was defined as total daily area under the plasma concentration-time profile from time 0 to 24 hours at steady-state. The geometric coefficient of variation is expressed in percentage.
Renal Clearance (CLr) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.
Renal Clearance (CLr) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau). AUCtau was defined as area under the concentration-time profile from time 0 to time tau. The geometric coefficient of variation is expressed in percentage.

18 secondary outcomes

Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
Clearance (CL) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
Clearance (CL) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Aztreonam
Time frame: Post dose on day 1 and day 4
Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Avibactam
Time frame: Post dose on day 1 and day 4
Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Aztreonam
Time frame: Post dose on day 4
Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Avibactam
Time frame: Post dose on day 4
Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Aztreonam
Time frame: Post dose on day 4
Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Avibactam
Time frame: Post dose on day 4
Number of Participants With an Adverse Event (AE)
Time frame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Number of Participants With Abnormal Vital Signs
Time frame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Number of Participants With Abnormal Electrocardiograms (ECGs)
Time frame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Number of Participants With Abnormal Laboratory Assessments
Time frame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)

Results and safety

Results posted to the registry on 28 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZTREONAM-AVIBACTAM (ATM-AVI)	12	12

Primary outcome: Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam

Time frame: Post dose on day 1 and day 4. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (ug/mL)

Measure	AZTREONAM-AVIBACTAM (ATM-AVI) n = 12
Day 1	69.44 (15)
Day 4	79.66 (12)

Population analysed: The analysis population included all participants who received at least one dose of investigational product (ATM-AVI) and had at least one of the PK parameters of interest.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam

Time frame: Post dose on day 1 and day 4. Geometric mean (Geometric Coefficient of Variation). Unit: ug/mL

Measure	AZTREONAM-AVIBACTAM (ATM-AVI) n = 12
Day 1	13.93 (16)
Day 4	14.03 (14)

Population analysed: The analysis population included all participants who received at least one dose of investigational product (ATM-AVI) and had at least one of the PK parameters of interest.

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam

Time frame: Post dose on day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/millilitre/hour (ng*hr/mL)

Measure	AZTREONAM-AVIBACTAM (ATM-AVI) n = 12
Value	236.7 (14)

Population analysed: The analysis population included all participants who received at least one dose of investigational product (ATM-AVI) and had at least one of the PK parameters of interest.

Primary outcome: Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam

Time frame: Post dose on day 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	AZTREONAM-AVIBACTAM (ATM-AVI) n = 12
Value	42.36 (15)

Population analysed: The analysis population included all participants who received at least one dose of investigational product (ATM-AVI) and had at least one of the PK parameters of interest.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZTREONAM-AVIBACTAM (ATM-AVI)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41709845Wang J, He J, Wu J, Zhang J, Ma Y, Ren X, Wei H, Zhang C, Zhu H, Raber SR, Cong S. Pharmacokinetics of Aztreonam-Avibactam After Single- and Multiple-Dose Administration: A Phase 1, Open-Label Study in Healthy Chinese Participants and Ethnic Comparison with Non-Chinese Participants. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e70040. doi: 10.1002/cpdd.70040.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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 Aztreonam-Avibactam in people with Healthy, run by Pfizer at 1 site in China.

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 5 inclusion and 8 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 28 Jul 2023. 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 China. 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. 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 28 Jul 2023). 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?

Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam (time frame: Post dose on day 1 and day 4). The study lists 16 primary outcomes in all. 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 NCT04973826, 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 28 Jul 2023.