6 completed. 4 Phase 1, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers 1 µCi of 14C-AAI101 + 500 mg AAI101 - Healthy | Phase 1 | Completed | Allecra | 8 | 2018-11-27 | 2019-02-26 |
| Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections cefepime/AAI101 combination, Piperacillin/tazobactam - Urinary Tract Infections | Phase 3 | Completed | Allecra | 1043 | 2018-09-24 | 2020-03-10 |
| Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI Cefepime 1G - 2G / AAI101 0.5G - 0.75G, cefepime 1 g or cefepime 2 g - Urinary Tract Infections | Phase 2 | Completed | Allecra | 45 | 2017-09-05 | 2018-09-21 |
| Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects cefepime/AAI101 - PK in Patients With Various Degrees of Renal Impairment | Phase 1 | Completed | Allecra | 30 | 2017-09-01 | 2022-06-28 |
| Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF) Cefepime 2 gram - Healthy Subjects | Phase 1 | Completed | Allecra | 19 | 2017-07-01 | 2020-07-14 |
| Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers AAI101 i.v., Saline 0.9% infusion, Piperacillin i.v. - Healthy | Phase 1 | Completed | Allecra | 56 | 2013-10-10 | 2018-09-26 |
enmetazobactam (5) · Cefepime (3) · Monobactams (1) · Piperacillin, Tazobactam Drug Combination (1) · Sodium Chloride (1)
Hungary (3) · Czechia (2) · Poland (2) · Slovakia (2) · Ukraine (2) · United States (2) · Argentina (1) · Belarus (1) · Bulgaria (1) · Croatia (1) · Estonia (1) · Georgia (1) · Latvia (1) · Lithuania (1) · Mexico (1)