A Phase 1 interventional study of XNW4107, Imipenem/Cilastatin in Bacterial Infections, sponsored by Evopoint Biosciences Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Evopoint Biosciences Inc. · Phase 1, Interventional, and Basic science
This is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin administered intravenously.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 21 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Evopoint Biosciences Inc. is the lead sponsor of 21 studies on the registry; 12 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
1． Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening;
Exclusion Criteria:
History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant;
Each subject will receive a total of five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin via IV infusion administered every 6 hours with each administration infused over 60 minutes.
Drug: XNW4107, Imipenem/Cilastatin
Five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin
Area under the concentration curve (AUC) from time zero to the last quantifiable sample (AUC0-t) of plasma PK and lung penetration of XNW4107, imipenem and cilastatine in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
AUC extrapolated to infinity (AUC0-∞) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
AUC from time zero to 6 hours after start of the infusion (AUC0-6) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 6 hours post- fifth dose
Maximum concentration (Cmax) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
Minimum concentration (Cmin) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
Time to Cmax (tmax) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
The terminal-phase half-life (t1/2) of plasma PK and lung penetration of XNW4107, imipenem and cilastatin in healthy adult volunteers.
Time frame: From baseline to 12 hours post- fifth dose
Number of participants with treatment-related adverse events of Hematology as assessed by CTCAE v5.0
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Hematology including White cell count with differential (total and % of neutrophil, lymphocyte, monocyte, eosinophil, and basophil), red blood cell count in m/mm³, hemoglobin in g/dL, hematocrit in % and platelet count m/mm³.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Coagulation as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Coagulation including Prothrombin time in seconds, activated partial thromboplastin time in seconds and International Normalized Ratio (INR).
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Biochemistry as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Biochemistry including Sodium in mmol/L, calcium in mg/dL, phosphate in mg/dL, potassium in mmol/L, chloride in mmol/L, glucose in mg/ dl, BUN in mg/dl, uric acid in mg/dl, creatinine in mg/dL, creatine kinase in IU/L, creatinine clearance calculated in ml/ min/1.73m² , total bilirubin in mg/dL, direct bilirubin in mg/dL, alkaline phosphatase in IU/L, ALT in IU/L, AST in IU/L, lactate dehydrogenase in IU/L, gamma-glutamyl transferase in IU/L, total protein in g/dL, albumin in g/dL, triglycerides in mg/dL, and cholesterol in mg/dL.
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Urinalysis as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in clinical laboratory values of Urinalysis Specific gravity, pH, leukocyte esterase, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen. \[Time
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Physical Examination as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in Physical Examination of the following body systems: HEENT; cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance, and in kilograms, height in meters and weight and height will be combined to report BMI in kg/m².
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of Vital Signs as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in Vital Signs (Systolic and diastolic blood pressure in mmHg, heart rate in Beats per min, respiratory rate in Breaths per min, and oral temperature in Degree celsius).
Time frame: From baseline up to Day 9
Number of participants with treatment-related adverse events of 12-Lead Electrocardiogram (ECG) as assessed by CTCAE v5.0.
Safety and tolerability up to the last study visit as assessed by the incidence of treatment-emergent AEs along with clinically significant changes from baseline in 12-Lead Electrocardiogram including heart rate(bpm), RR interval(ms), PR interval(ms), QRS(ms), QT(ms) and QTcF(ms).
Time frame: From baseline up to Day 9
Plan to share: No
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Evopoint Biosciences Inc.