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
Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FL058 500mg and Meropenem 1000mg | Experimental | FL058 500mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects) |
|
| FL058 1000mg and Meropenem 1000mg | Experimental | D1 FL058 1000mg(8 subjects) and FL058 Placebo(2 subjects); D4 Meropenem 1000mg(8 subjects) and Meropenem Placebo(2 subjects); D7~ D15 FL058 1000mg and Meropenem 1000mg (8 subjects); FL058 Placebo and Meropenem 1000mg(2 subjects) |
|
| FL058 1000mg and Meropenem 2000mg (IV 120min) | Experimental | FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) |
|
| FL058 1000mg and Meropenem 2000mg (IV 180min) | Experimental | FL058 1000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FL058 500mg and Meropenem 1000mg( IV 120min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events [Safety and Tolerability] | Day 1 to Day 24 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38054726 | Derived | Huang Z, Yang X, Jin Y, Yu J, Cao G, Wang J, Hu Y, Dai J, Wu J, Wei Q, Tian Y, Yu S, Zhu X, Mao X, Liu W, Liang H, Zheng S, Ju Y, Wang Z, Zhang J, Wu X. First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0133023. doi: 10.1128/aac.01330-23. Epub 2023 Dec 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FL058 2000mg and Meropenem 2000mg | Experimental | FL058 2000mg and Meropenem 2000mg (8 subjects); FL058 Placebo and Meropenem 2000mg(2 subjects) |
|
| FL058 Placebo and Meropenem 1000mg( IV 120min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| FL058 1000mg( IV 120min) | Drug | D1 qd; |
|
| FL058 Placebo ( IV 120min) | Drug | D1 qd; |
|
| Meropenem 1000 mg ( IV 120min) | Drug | D4 qd; |
|
| Meropenem Placebo ( IV 120min) | Drug | D4 qd; |
|
| FL058 1000mg and Meropenem 1000mg ( IV 120min) | Drug | D7 qd; D8~ D14 q8h; D15 qd; |
|
| FL058 Placebo and Meropenem 1000mg ( IV 120min) | Drug | D7 qd; D8~ D14 q8h; D15 qd; |
|
| FL058 1000mg and Meropenem 2000mg ( IV 120min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| FL058 Placebo and Meropenem 2000m( IV 120min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| FL058 1000mg and Meropenem 2000mg ( IV 180min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| FL058 Placebo and Meropenem 2000m( IV 180min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| FL058 2000mg and Meropenem 2000mg( IV 180min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| FL058 Placebo and Meropenem 2000mg( IV 180min) | Drug | D1 qd; D2~ D8 q8h; D9 qd |
|
| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided