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| Name | Class |
|---|---|
| Clinartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANT3310 and Meropenem (MEM) | Experimental | Each participant will receive a total of 3 doses of MEM-ANT3310, infused intravenously over 3 hours every 8 hours (i.e., 0 hour, 8 hours, and 16 hours relative to start of the first infusion). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANT3310 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Day 1 to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Burr Ross, MD | Pulmonary Associates, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85032 | United States |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Meropenem | Drug | 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. |
|
Pharmacokinetic parameter of ANT3310 and Meropenem in plasma
| From pre-dose to 8 hours post-last-dose |
| 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 | 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 | 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 | 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 | From pre-dose to 8 hours post-last-dose |
| Number of participants who discontinue due to a TEAE. | Percentage of participants who discontinue due to a TEAE. | 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 | 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 | 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 | From Day 1 to Day 11 |
| Number of infusion site reactions to assess local venous tolerability | From Day 1 to Day 11 |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |