scholarly journals A Randomized, Single-Center, Double-Blind, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Imarikiren in Healthy Adult Nonelderly and Elderly Male Subjects

2018 ◽  
Vol 58 (11) ◽  
pp. 1516-1524 ◽  
Author(s):  
Kumi Matsuno ◽  
Shingo Tanaka ◽  
Takamasa Hashimoto ◽  
Hiroyuki Nakamichi ◽  
Tomoya Kagawa ◽  
...  
Keyword(s):  
Multiple Dose ◽  
Healthy Adult ◽  
Phase 1 ◽  
Single Center ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Elderly Male ◽  
Phase 1 Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Male Subjects

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics following Administration of Single and Multiple Doses of the Anti-Staphylococcal Lysin, LSVT-1701, in Healthy Adult Subjects

2022 ◽  
Author(s):  
Mary Beth Wire ◽  
Soo Youn Jun ◽  
In-Jin Jang ◽  
Seung-Hwan Lee ◽  
Jun Gi Hwang ◽  
...  
Keyword(s):  
Healthy Adult ◽  
Phase 1 ◽  
Infusion Site ◽  
Healthy Male ◽  
C Reactive Protein ◽  
Phase 1 Study ◽  
Reactive Protein ◽  
Male Subjects ◽  
Common Teaes ◽  
Dose Proportional

Thirty-two healthy male subjects (8 per cohort) were randomized 6:2 to active:placebo. LSVT-1701, an anti-staphylococcal lysin, was administered intravenously as a 6 mg/kg single dose and as 1.5, 3, and 4.5 mg/kg twice daily for 4 days. LSVT-1701 exposure increased in a greater than dose proportional manner and did not accumulate. Treatment-emergent adverse events (TEAEs) were predominantly of mild intensity. The most common TEAEs were chills, pyrexia, headache, infusion site events, cough, rhinorrhea, and increases in C-reactive protein.

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