Evidence map›Paper›PMID 35045208›Full record

Trial reportClinical and translational science2022

Single-dose of LC51-0255, a selective S1P

Sang Won Lee, Inyoung Hwang, Jaeseong Oh, SeungHwan Lee, In-Jin Jang, Kyung-Sang Yu

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Single-dose of LC51-0255, a selective S1PClinical and translational science · 2022
    Trial
  2. Advancing therapeutic frontiers: a pipeline of novel drugs for UC management.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026
    Review
  3. Challenges and Future Trends in Atopic Dermatitis.International journal of molecular sciences · 2023
    Review
  4. Article
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.

Sang Won LeeDepartment of Clinical Pharmacology and Therapeutics, Hanyang University Seoul Hospital, Seoul, South Korea.
Inyoung HwangDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea.
Jaeseong OhDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea.
SeungHwan LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea.
In-Jin JangDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea.
Kyung-Sang YuDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reducing the peripheral absolute lymphocyte count (ALC) is a promising therapeutic approach in treating autoimmune diseases. LC51-0255 is a sphingosine-1-phosphate 1 receptor modulator, which is known to decrease the peripheral ALC. We aimed to assess the pharmacokinetics (PKs), pharmacodynamics (PDs), safety, and tolerability profiles of LC51-0255 after a single oral administration in healthy subjects. A randomized, double-blind, placebo-controlled, dose-escalation study was conducted in 50 healthy subjects. Each subject orally received LC51-0255 (0.25, 0.5, 1, 2, or 4 mg) or its matching placebo in an 8:2 ratio. Blood and urine samples were collected to assess the PKs, and PDs was evaluated using peripheral ALC and 24-h hourly heart rate data. Safety and tolerability were assessed by monitoring treatment emergent adverse events (TEAEs), vital signs, 12-lead electrocardiogram (ECG), continuous 24-h ECG (via Holter monitoring), clinical laboratory tests, ophthalmologic tests, pulmonary function tests, and physical examinations. A single dose of LC51-0255 reduced ALC and heart rate in a reversible and dose-dependent manner. Systemic exposure of LC51-0255 increased dose-dependently and its half-life ranged from 72.2 to 134.0 h. ALC and the systemic exposure of LC51-0255 seemed to be negatively correlated. LC51-0255 was well-tolerated up to 2 mg, and the most common TEAE was bradycardia. The results of this study suggest that LC51-0255 can be developed into a beneficial treatment option for autoimmune disease.

Indexed as

Dose-Response Relationship, DrugAdministration, OralDouble-Blind MethodHalf-LifeHealthy VolunteersHumansLymphocyte Count

Identifiers

PMID35045208
PMCPMC9010277

What OpenQuestion holds

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Registered trials

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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.