Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809-3017, United States
NCT Number: NCT04801043
This is a Phase 1, randomized, double-blind, placebo-controlled study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-min (± 3 min) IV infusion in healthy adult young females and in healthy adult elderly males and females.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Orlando, Florida, 32809-3017, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
9.Positive urine drug or alcohol testing at screening or check-in (Day -1).
10.Use of prescription medications (with the exception of hormone replacement therapy and contraceptives), including nonsteroidal anti-inflammatory drugs, sucralfate, or herbal preparations within 7 days before Check in (Day -1), or use of an over-the-counter medication, acetaminophen (>2 g/day), vitamins, or supplements (including fish liver oils) within 7 days before Check in (Day -1); or probenecid or valproic acid within 30 days before Check in (Day -1).
XNW4107 250mg IV over 60 minutes as a single dose
500mg/500mg IV over 60 minutes as a single dose
Matching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose
Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline to 24 hours post-dose
Time frame: From baseline to 48 hours post-dose
Time frame: From baseline up to 10 days post-dose
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 %, mean corpuscular volume and platelet count m/mm³.
Time frame: From baseline up to 10 days post-dose
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 10 days post-dose
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 3 days post-dose
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 10 days post-dose
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 10 days post-dose
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 10 days post-dose
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.
Evopoint Biosciences Inc.
Industry
A Phase 1, Single-Dose, Randomized, Double Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of XNW4107 for Injection in Healthy Adult Young Females and in Healthy Adult Elderly Males and Females.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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