Trial reportAntimicrobial agents and chemotherapy2014
Safety, tolerability, and pharmacokinetics of intravenous nemonoxacin in healthy chinese volunteers.
Trial report in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01944774 (A Multi-Center, Randomized, Double-Blind, Parallel Comparative, Phase II Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Versus Moxifloxacin in Treating Adult Patients With Community-Acquired Pneumonia), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Center, Randomized, Double-Blind, Parallel Comparative, Phase II Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Versus Moxifloxacin in Treating Adult Patients With Community-Acquired Pneumonia
Who cites it
7 citing papers in PubMed, 10 citations in OpenAlex.
- Pharmacokinetics and pharmacodynamics of multiple-dose intravenous nemonoxacin in healthy Chinese volunteers.Antimicrobial agents and chemotherapy · 2015Trial
- Evaluation of the efficacy, safety, and economy of nemonoxacin injection versus moxifloxacin injection in the treatment of community-acquired pneumonia.Frontiers in pharmacology · 2026Article
- Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile?Pharmaceutics · 2023Review
- Nemonoxacin Enhances Antibacterial Activity and Anti-Resistance Mutation Ability of Vancomycin against Methicillin-Resistant Staphylococcus aureus in anAntimicrobial agents and chemotherapy · 2022Article
- Nemonoxacin Has Immunoprotective Effects on Reducing Mortality in Lipopolysaccharide-Induced Mouse Sepsis Model.Inflammation · 2020Article
- Pharmacotherapy of Lower Respiratory Tract Infections in Elderly-Focused on Antibiotics.Frontiers in pharmacology · 2019Review
- Chemical structure and pharmacokinetics of novel quinolone agents represented by avarofloxacin, delafloxacin, finafloxacin, zabofloxacin and nemonoxacin.Annals of clinical microbiology and antimicrobials · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nemonoxacin (TG-873870) is a novel nonfluorinated quinolone with potent broad-spectrum activity against Gram-positive, Gram-negative, and atypical pathogens, including vancomycin-nonsusceptible methicillin-resistant Staphylococcus aureus (MRSA), quinolone-resistant MRSA, quinolone-resistant Streptococcus pneumoniae, penicillin-resistant S. pneumoniae, and erythromycin-resistant S. pneumoniae. This first-in-human study was aimed at assessing the safety, tolerability, and pharmacokinetic properties of intravenous nemonoxacin in healthy Chinese volunteers. The study comprised a randomized, double-blind, placebo-controlled, dose escalating safety and tolerability study in 92 subjects and a randomized, single-dose, open-label, 3-period Latin-square crossover pharmacokinetic study in 12 subjects. The study revealed that nemonoxacin infusion was well tolerated up to the maximum dose of 1,250 mg, and the acceptable infusion rates ranged from 0.42 to 5.56 mg/min. Drug-related adverse events (AEs) were mild, transient, and confined to local irritation at the injection site. The pharmacokinetic study revealed that after the administration of 250, 500, and 750 mg of intravenous nemonoxacin, the maximum plasma drug concentration (Cmax) values were 4.826 μg/ml, 7.152 μg/ml, and 11.029 μg/ml, respectively. The corresponding values for the area under the concentration-time curve from 0 to 72 hours (AUC0-72 h) were 17.05 μg · h/ml, 39.30 μg · h/ml, and 61.98 μg · h/ml. The mean elimination half-life (t1/2) was 11 h, and the mean cumulative drug excretion rate within 72 h ranged from 64.93% to 77.17%. Volunteers treated with 250 to 750 mg nemonoxacin exhibited a linear dose-response relationship between the AUC0-72 h and AUC0-∞. These findings provide further support for the safety, tolerability, and pharmacokinetic properties of intravenous nemonoxacin. (This study has been registered at ClinicalTrials.gov under registration no. NCT01944774.).
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