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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Intravenous Ascending Dose of ANT3310 | Experimental |
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| Part A: Single Intravenous Dose of Matching placebo | Placebo Comparator |
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| Part B: Multiple Intravenous Ascending Doses of ANT3310 | Experimental |
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| Part B: Multiple Intravenous Ascending Doses of Matching Placebo | Placebo Comparator |
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| Part C: ANT3310 + Meropenem | Experimental | Participants will receive a single intravenous dose of ANT3310 or Meropenem in one of the 2 treatment sequences followed by the repeat administrations of ANT3310 + Meropenem. |
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| Part C: ANT3310 Placebo + Meropenem Placebo | Placebo Comparator | Participants will receive a single dose of ANT3310-placebo or Meropenem-placebo in one of the 2 treatment sequences followed by repeat administrations of ANT3310-placebo + Meropenem-placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANT3310 | Drug | ANT3310 will be infused over 3 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD): Maximum Plasma Concentration (Cmax) of single i.v. ascending doses of ANT3310 alone | Pharmacokinetic parameter of ANT3310 in plasma | 24 hours |
| Part A (SAD): Area under the concentration time curve (AUC) of single i.v. ascending doses of ANT3310 alone |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Part C with co-administration of meropenem:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Hays, MD | Biotrial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial | Rennes | 35042 | France |
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| ANT3310-placebo |
| Drug |
ANT3310-placebo will be infused over 3 hours |
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| ANT3310 | Drug | ANT3310 will be infused over 3 hours every 8 hours |
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| ANT3310-placebo | Drug | ANT3310-placebo will be infused over 3 hours every 8 hours |
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| ANT3310-placebo | Drug | 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. |
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| ANT3310 | Drug | 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. |
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| Meropenem | Drug | 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. |
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| Meropenem-placebo | Drug | 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. |
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Pharmacokinetic parameter of ANT3310 in plasma |
| 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 | 24 hours |
| Part A (SAD): Half-time (t1/2) of single i.v. ascending doses of ANT3310 alone | Pharmacokinetic parameter of ANT3310 in plasma | 24 hours |
| Part B (MAD): Maximum Plasma Concentration (Cmax) of multiple i.v. ascending doses of ANT3310 alone | Pharmacokinetic parameter of ANT3310 in plasma | Day 1, Day 7 |
| Part B (MAD): Area under the concentration time curve (AUC) of multiple i.v. ascending doses of ANT3310 alone | Pharmacokinetic parameter of ANT3310 in plasma | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Day 11 |
| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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