A Phase 1 Study To Evaluate Safety and Pharmacokinetics following Administration of Single and Multiple Doses of the Antistaphylococcal Lysin LSVT-1701 in Healthy Adult Subjects

Thirty-two healthy male subjects (8 per cohort) were randomized 6:2 to active:placebo. LSVT-1701, an antistaphylococcal 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. Thirty-two healthy male subjects (8 per cohort) were randomized...

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Published inAntimicrobial agents and chemotherapy Vol. 66; no. 3; p. e0184221
Main Authors Wire, Mary Beth, Jun, Soo Youn, Jang, In-Jin, Lee, Seung-Hwan, Hwang, Jun Gi, Huang, David B.
Format Journal Article
LanguageEnglish
Published United States American Society for Microbiology 15.03.2022
Subjects
Adult
Bacteriophages
Dose-Response Relationship, Drug
Double-Blind Method
Headache
Healthy Volunteers
Humans
Male
Pharmacology
pharmacokinetics
lysin
LSVT-1701
SAL200
bacteriophage
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Summary:Thirty-two healthy male subjects (8 per cohort) were randomized 6:2 to active:placebo. LSVT-1701, an antistaphylococcal 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. Thirty-two healthy male subjects (8 per cohort) were randomized 6:2 to active:placebo. LSVT-1701, an antistaphylococcal 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. (This study has been registered at ClinicalTrials.gov under identifier NCT03446053.)
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The authors declare a conflict of interest. M.B.W. and D.B.H. are consultants for Lysovant Sciences.
ISSN:0066-4804
1098-6596
1098-6596
DOI:10.1128/aac.01842-21