This is an open-label, non-randomized, single-center, repeated i.v. doses, Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of a combination of MEM-ANT3310 in healthy adult female and male participants who will undergo a single bronchoalveolar lavage (BAL) via a standardized fiberoptic bronchoscopy to evaluate and compare the pharmacokinetics characteristics of ANT3310 and meropenem (MEM) in plasma and epithelial lining luid (ELF).
There will be 25 participants enrolled in the study. Each participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours. Each participant will undergo a single bronchoscopy at the assigned BAL sampling time. Blood samples will be collected. Participants will be monitored for adverse events from study center admittance through the EoS visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
26
ANT3310 will be administered in combination with Meropenem. Participants will receive 3 intravenous infusions of the combination MEM-ANT3310 every 8 hours. Infusions will be delivered through an infusion line over 3 hours at a constant rate.
Meropenem will be administered in combination with ANT3310. Participants will receive 3 intravenous infusions of the combination MEM-ANT3310 every 8 hours. Infusions will be delivered through an infusion line over 3 hours at a constant rate.
Pulmonary Associates, PA
Phoenix, Arizona, United States
Maximum Plasma Concentrations (Cmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Area under the concentration-time curve from 0 to 8 hours post-dose (AUC0-8h) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Percent penetration of ANT3310 and Meropenem in epithelial lining fluid (ELF) after repeated i.v. infusions of a combination of ANT3310 and Meropenem
ratio (%) of AUC0-8h of ELF-to-plasma for ANT3310 and Meropenem
Time frame: From pre-dose to 8 hours post-last-dose
Time from dosing to maximum observed plasma concentration (tmax) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Apparent terminal elimination half-life (t1/2λz) of ANT3310 and Meropenem in plasma after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
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Terminal phase elimination rate constant (λz) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Apparent total body clearance at steady-state (CLss) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Apparent volume of distribution at steady-state (Vss) of ANT3310 and Meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
Time frame: From pre-dose to 8 hours post-last-dose
Apparent elimination half-life (t1/2,ELF) of ANT3310 and Meropenem in ELF after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Pharmacokinetic parameter of ANT3310 and Meropenem in ELF
Time frame: From pre-dose to 8 hours post-last-dose
Number and severity of treatment-emergent adverse event (TEAE) to evaluate the safety and tolerability of ANT3310 and meropenem after repeated i.v. infusions of a combination of ANT3310 and Meropenem
Percentage of participants experiencing ≥ one TEAE by seriousness, intensity, and relatedness from baseline through end of study visit
Time frame: From Day 1 to Day 11
Number of participants who discontinue due to a TEAE.
Percentage of participants who discontinue due to a TEAE.
Time frame: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for safety laboratory tests at least once post-dose
Percentage of participants with clinically significant abnormal values for safety laboratory tests at least once post-dose
Time frame: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose
Percentage of participants with clinically significant abnormal values for vital signs (blood pressure, pulse rate, and body temperature) measurement at least once post-dose
Time frame: From Day 1 to Day 11
Number of participants with clinically significant abnormal values for safety electrocardiogram (ECG) parameters at least once post-dose
Percentage of participants with clinically significant abnormal values for safety electrocardiogram (ECG) parameters at least once post-dose
Time frame: From Day 1 to Day 11
Number of infusion site reactions to assess local venous tolerability
Time frame: From Day 1 to Day 11