scholarly journals SP428A RANDOMIZED, SINGLE-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS (PK), AND PHARMACODYNAMICS (PD) OF TAK-272 IN HEALTHY ADULT NON-ELDERLY AND ELDERLY MALE SUBJECTS

2017 ◽  
Vol 32 (suppl_3) ◽  
pp. iii265-iii266 ◽  
Author(s):  
K Matsuno ◽  
S Tanaka ◽  
T Hashimoto ◽  
H Nakamichi ◽  
E Komura
Keyword(s):  
Multiple Dose ◽  
Healthy Adult ◽  
Phase 1 ◽  
Single Center ◽  
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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