The purpose of this study is to evaluate the safety and tolerability of single and multiple intravenous ascending doses of ANT3310, a novel, specific, competitive inhibitor of serine β-lactamases, alone and in combination with meropenem in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
72
ANT3310 will be infused over 3 hours
ANT3310-placebo will be infused over 3 hours
ANT3310 will be infused over 3 hours every 8 hours
Biotrial
Rennes, France
Number and severity of Treatment Emergent Adverse Events (TEAE) to evaluate the safety and tolerability profile of single and multiple intravenous ascending doses of ANT3310 alone (Part A and B) and in combination with meropenem (Part C)
Percentage of subjects who experience at least one TEAE, including abnormalities in vital signs, physical examinations, laboratory safety tests and ECG, by seriousness, intensity, and relatedness
Time frame: up to 11 days
Part A (SAD): Maximum Plasma Concentration (Cmax) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: 24 hours
Part A (SAD): Area under the concentration time curve (AUC) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: 24 hours
Part A (SAD): Time to maximum plasma concentration (Tmax) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: 24 hours
Part A (SAD): Half-time (t1/2) of single i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: 24 hours
Part B (MAD): Maximum Plasma Concentration (Cmax) of multiple i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: Day 1, Day 7
Part B (MAD): Area under the concentration time curve (AUC) of multiple i.v. ascending doses of ANT3310 alone
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ANT3310-placebo will be infused over 3 hours every 8 hours
ANT3310-placebo will be infused over 3 hours as a single dose as part of the drug drug interaction study, then every 8 hours as part of the repeat doses study.
ANT3310 will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.
Meropenem will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.
Meropenem-placebo will be infused over 3 hours as a single dose as part of the drug-drug interaction study, then every 8 hours as part of the repeat doses study.
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: Day 1, Day 7
Part B (MAD): Time to maximum plasma concentration (Tmax) of multiple i.v. ascending doses of ANT3310 alone
Pharmacokinetic parameter of ANT3310 in plasma
Time frame: Day 1, Day 7
Part C (DDI and combination): Maximum Plasma Concentration (Cmax) of a single i.v. dose of ANT3310 and meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Time frame: Day 1, Day 3, Day 5
Part C (DDI and combination): Area under the concentration time curve (AUC) of a single i.v. dose of ANT3310 and meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Time frame: Day 1, Day 3, Day 5
Part C (DDI and combination): Time to maximum plasma concentration (Tmax) of a single i.v. dose of ANT3310 and meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Time frame: Day 1, Day 3, Day 5
Part C (DDI and combination): Maximum Plasma Concentration (Cmax) of multiple i.v. dose of ANT3310 co-administered with meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Time frame: Day 11
Part C (DDI and combination): Area under the concentration time curve (AUC) of multiple i.v. dose of ANT3310 co-administered with meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Time frame: Day 11
Part C (DDI and combination): Time to maximum plasma concentration (Tmax) of multiple i.v. dose of ANT3310 co-administered with meropenem
Pharmacokinetic parameter of ANT3310 and meropenem in plasma
Time frame: Day 11