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This is a 3-part, first-in-human study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with imipenem/cilastatin for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose Study | Experimental | Six XNW4107 doses ( 50-1250 mg ), each administered as a single dose with 60-minute IV infusion |
|
| Multiple Ascending Dose Study | Experimental | Three XNW4107 doses (167-500 mg), each administered as 60-minute IV infusion every 6 hours for 7 days |
|
| Multiple Dose Study of XNW4107 +Imipenem/Cilastatin | Experimental | 500 mg XNW4107 co-administered with imipenem/cilastatin as 60-minute IV infusion every 6 hours for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XNW4107 | Drug | Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by number of participants experiencing adverse events | Number of participants who experience adverse events in different grades, as defined by Common Terminology for Adverse Events (CTCAE) v5.0 | Change from baseline up to day 43 post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Le | Evopoint Biosciences Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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