Trial reportAntimicrobial agents and chemotherapy2017
Pharmacokinetics and Tolerance of the Phage Endolysin-Based Candidate Drug SAL200 after a Single Intravenous Administration among Healthy Volunteers.
Trial report in Antimicrobial agents and chemotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01855048 (A Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Pharmacokinetics and Phyarmacodynamcs of a Single Intravenous Dose of N-Rephasin® SAL200, in Healthy Male Valunteers), which is not on this map. Cited by 108 papers.
What it found
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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.
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.
A Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Pharmacokinetics and Phyarmacodynamcs of a Single Intravenous Dose of N-Rephasin® SAL200, in Healthy Male Valunteers
Who cites it
108 citing papers in PubMed, 174 citations in OpenAlex.
- 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.Antimicrobial agents and chemotherapy · 2022Trial
- Inhalable bacteriophage endolysins: a novel therapeutic strategy for drug-resistant bacterial pulmonary infections - a comprehensive review.Annals of medicine · 2026Review
- LYSG101: a potent chimeric lysin with therapeutic potential for combatingAntimicrobial agents and chemotherapy · 2026Article
- Prophages in Skin Pathogens: From Virulence to Therapy.Pathogens (Basel, Switzerland) · 2026Review
- Burn Infections and Sepsis: Challenges and Future Prospects of Antibacterial Therapy.Antibiotics (Basel, Switzerland) · 2026Review
- Nanoengineered γ MnOLife (Basel, Switzerland) · 2026Article
- Enhancing stability and safety of chimeric peptidoglycan hydrolases by linker engineering.Applied microbiology and biotechnology · 2026Article
- Clinical implementation of endolysins targeting gram-positive bacteria points toward a combination strategy with standard-of-care antibiotics: a selective review.European journal of medical research · 2026Review
- Phage endolysins as alternative antimicrobials: mechanisms, clinical progress, and emerging resistance frameworks.Frontiers in microbiology · 2026Review
- Next-generation antimicrobials: A review of phage lysins as precision weapons against drug-resistant pathogens.Virulence · 2025Review
- Phage and enzyme therapies in wound infections: From lab to bedside.Chinese medical journal · 2025Review
- Characterization of an enterococcal phage endolysin as a potential antimicrobial agent against Streptococcus suis.Veterinary research · 2025Article
- Global health perspectives on antibacterial drug discovery and the preclinical pipeline.Nature reviews. Microbiology · 2025Review
- Marine Bacteriophages as Next-Generation Therapeutics: Insights into Antimicrobial Potential and Application.Viruses · 2025Review
- Phage and Endolysin Therapy Against Antibiotics Resistant Bacteria: From Bench to Bedside.MedComm · 2025Review
- Activity of GS-linked chimeric endolysin CHAPk-SH3bk against methicillin-resistant Staphylococcus aureus biofilms: an in-vitro, ex-vivo and in-vivo study.NPJ biofilms and microbiomes · 2025Article
- [Phage endolysins-a novel class of antibacterial agents with a wide range of applications].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2025Review
- Modifying Pharmacokinetic Properties of the Gram-Negative Bacteria Targeting Endolysin ML06 Without Affecting Antibacterial Activity.International journal of molecular sciences · 2025Article
- Phage therapy for Klebsiella pneumoniae: Understanding bacteria-phage interactions for therapeutic innovations.PLoS pathogens · 2025Review
- Phage-derived proteins: Advancing food safety through biocontrol and detection of foodborne pathogens.Comprehensive reviews in food science and food safety · 2025Review
48 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study was a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dosing, and dose-escalating study of intravenous SAL200. It is a new candidate drug for the treatment of antibiotic-resistant staphylococcal infections based on a recombinant form of the phage endolysin SAL-1. The study evaluated the pharmacokinetics, pharmacodynamics, and tolerance among healthy male volunteers after the intravenous infusion of single ascending doses of SAL200 (0.1, 0.3, 1, 3, and 10 mg/kg of body weight). SAL200 was well tolerated, and no serious adverse events (AEs) were observed in this clinical study. Most AEs were mild, self-limiting, and transient. The AEs reported in more than three participants were fatigue, rigors, headache, and myalgia. No clinically significant values with respect to the findings of clinical chemistry, hematology, and coagulation analyses, urinalysis, vital signs, and physical examinations were observed, and no notable trends in our electrocardiogram (ECG) results for any tested dose were noticed. A greater-than-dose-proportional increase with regard to systemic exposure and the maximum serum concentration was observed when the SAL200 dose was increased from 0.1 mg/kg to 10 mg/kg. This investigation constitutes the first-in-human phase 1 study of an intravenously administered, phage endolysin-based drug. (This study has been registered at ClinicalTrials.gov under identifier NCT01855048 and at the Clinical Research Information Service [https://cris.nih.go.kr/cris/] under identifier KCT0000968.).
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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.