Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascending single dose of OP0595 | Experimental |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OP0595 | Drug | Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety from baseline through the end of the study | Number of patients with adverse events | Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK parameters of OP0595 and its metabolites | Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss | Day 1 to Day 2 |
| Urine PK parameters of OP0595 and its metabolites | Ae, Ae0-t, Ae0-t/Dose, CLr |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mitsuharu Egawa | Meiji Seika Pharma Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth | Western Australia | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32041717 | Derived | Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608518 | nacubactam |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation |
|
| Day 1 to Day 2 |