FL058 / Qilu Pharma - LARVOL DELTA

Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Infectious Disease

FL058, a novel β-lactamase inhibitor, increases the anti-Mycobacterium abscessus activity of imipenem. (PubMed, Int J Antimicrob Agents) - "The elevated anti-MABC activity exhibited by imipenem combined with FL058 suggests a potential new approach to treating MABC infections."

Journal • Infectious Disease

In vitro pharmacokinetics/pharmacodynamics of FL058 (a novel beta-lactamase inhibitor) combined with meropenem against carbapenemase-producing Enterobacterales. (PubMed, Front Pharmacol) - "The PK/PD index of %fT > 1 mg/L can provide a basis for evaluating clinical dosing regimens for FL058 combined with meropenem. FL058 combined with meropenem might be a potential treatment for KPC- and/or OXA-48-producing Enterobacterales infection."

Journal • PK/PD data • Preclinical • Infectious Disease • Pneumonia

First-in-human study to evaluate the safety, tolerability, and population pharmacokinetic/pharmacodynamic target attainment analysis of FL058 alone and in combination with meropenem in healthy subjects. (PubMed, Antimicrob Agents Chemother) - P1 | "The recommended minimum dose of FL058/meropenem combination was 500 mg/1,000 mg by intravenous infusion over 2 h every 8 h based on target attainment analysis. The good safety, tolerability, and satisfactory PK profiles of FL058 alone and in combination with meropenem in this first-in-human study will support further clinical development of FL058 in combination with meropenem in patients with target infections (ClinicalTrials.gov identifiers: NCT05055687, NCT05058118, and NCT05058105)."

Combination therapy • Journal • P1 data • PK/PD data • Infectious Disease