Method for preventing or treating nosocomial pneumonia
An iatrogenic and pneumonia-related technology, applied in pharmaceutical formulations, chemical instruments and methods, antibody medical components, etc., can solve the problems of complicated management of Pseudomonas aeruginosa infection
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example 1
[0085] Example 1: Phase 1 Clinical Trial Study
[0086] Conduct a Phase 1, first-in-human, randomized, double-blind, placebo-controlled dose-escalation study evaluating the safety and tolerability of single ascending IV doses of MEDI3902 in healthy adult subjects. Among 42 subjects who received MEDI3902 at doses of 250 mg (n=3), 750 mg (n=15), 1500 mg (n=15) or 3000 mg (n=9) and 14 subjects who received placebo , adverse event (AE), PK and ADA data were collected until the last study visit (60 days post-dose / day 61). All AEs in both the MEDI3902 group and the placebo group were Grade 1 or 2 in severity. The most frequently reported adverse events were grade 1 or 2 infusion-related reactions (15 / 42 subjects [35.7%] in the overall MEDI3902 group; none in the placebo group) and grade 1 or 2 headache (across the 6 / 42 subjects [14.3%] in the MEDI3902 group; 2 / 14 subjects [14.3%] in the placebo group). Adverse events of special interest (AESI) included infusion-related reactions ...
example 2
[0089] Example 2: Phase 2b Clinical Trial Study
[0090] Approximately 429 subjects were recruited and administered at approximately 120 sites primarily in Europe in a Phase 2, randomized, double-blind, placebo-controlled, single-dose, dose-ranging proof of concept. Subjects will be randomly assigned in a 1:1:1 ratio to receive a single IV dose of 1500mg or 3000mg MEDI3902 or placebo. The dosing regimen may also become randomized 1:1 between a single IV dose of 1500 mg (or 3000 mg) MEDI3902 or placebo. Randomization will be stratified by geographic region and by whether subjects have received anti-P. aeruginosa antibiotic therapy (duration ≤72 hours) within 96 hours prior to randomization. Subjects will be followed until Day 50 (49 days after study product administration) ( figure 1 ).
[0091]For enrollment, subjects were required to be 18 years of age or older, in an intensive care unit, currently intubated and mechanically ventilated, and expected to remain intubated and...
example 3
[0143] Example 3: MEDI3902 reduces lethality in an acute pneumonia model under lower bacterial burden
[0144] The in vivo effects of MEDI3902 administration were studied in mice using an acute pneumonia model. Groups of mice (n=6) were injected intraperitoneally (IP) with decreasing concentrations of MEDI3902 (1.0 mg / kg, 0.5 mg / kg, or 0.2 mg / kg) or an isotype control IgG antibody (negative control, 0.75 mg / kg). ). Twenty-four hours after treatment, all mice were treated with 2 × 10 5 CFU Pseudomonas aeruginosa strain 6206 (1×LD 100 ) for intranasal infection. Such as image 3 As shown, all control-treated animals died of infection at 120 hours post-infection. However, MEDI3902 showed complete protection at all doses, even at 1×LD 100 The same is true below, suggesting that a lower target serum level of 1.7 μg / mL in humans would provide protection against most Pseudomonas aeruginosa strains.
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