At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Aztreonam-Avibactamdrug
Likely dose
Aztreonam-Avibactam 167 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Aztreonam-Avibactam for Healthy. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartAug 2021
Primary CompletionSep 2021
TodayJul 2026
First PostedJul 22, 2021
Enrollment StartAug 20, 2021
Primary CompletionSep 27, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.9 years ago
Interventions
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