Evidence map›Paper›PMID 35007129›Full record

Trial reportAntimicrobial agents and chemotherapy2022

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.

Mary Beth Wire, Soo Youn Jun, In-Jin Jang, Seung-Hwan Lee, Jun Gi Hwang, David B Huang

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03446053 (A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Dose-Escalating Phase 1b Study to Evaluate the Safety, PK, PD and Immunogenicity of N-Rephasin® SAL200 After Continuous IV Infusion in Healthy Volunteers), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.2field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03446053 phase1completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Dose-Escalating Phase 1b Study to Evaluate the Safety, PK, PD and Immunogenicity of N-Rephasin® SAL200 After Continuous IV Infusion in Healthy Volunteers

TypeinterventionalSponsorIntron Biotechnology, Inc.Ran2018 to 2019Enrolled33ConditionsHealthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus InfectionArmsN-Rephasin® SAL200, INT200-Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. [Phage endolysins-a novel class of antibacterial agents with a wide range of applications].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025
    Review
  7. Article
  8. Article
  9. Endolysins: targetingFrontiers in microbiology · 2025
    Review
  10. Article
  11. Article
  12. Article
  13. Persistent Methicillin-ResistantAntibiotics (Basel, Switzerland) · 2023
    Review
  14. Persistent Methicilin-Resistant Staphylococcus aureus Bacteremia: Resetting the Clock for Optimal Management.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  15. Review
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Mary Beth WireLysovant Sciences, Inc., New York, New York, USA.ORCID 0000-0001-8938-7288
Soo Youn JuniNtRON Biotechnology, Inc., Seongnam-si, Gyeonggi-do, Republic of Korea.
In-Jin JangDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Seung-Hwan LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Jun Gi HwangDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
David B HuangLysovant Sciences, Inc., New York, New York, USA.ORCID 0000-0001-8228-7911
Seoul National University Hospital · KRiNtRON (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.).

Indexed as

HeadacheAdultDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansMalebacteriophageLSVT-1701lysinpharmacokineticsSAL200

Identifiers

PMID35007129
PMCPMC8923190
OpenAlexW4206182690

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.