Evidence map›Paper›PMID 40065559›Full record

Trial reportClinical and translational science2025

Japanese Phase 1 Study for Global Development of Anti-TL1A Antibody PF-06480605: A Randomized, Placebo-Controlled, Single-Ascending Dose Study.

Kei Fukuhara, Srividya Neelakantan, Kenichi Furihata, Hirotoshi Yuasa, Nanzhi Shi, Yuichi Yamamoto, Kenneth E Hung

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

7 authors.

Kei FukuharaPfizer R&D Japan, Tokyo, Japan.ORCID 0009-0004-8680-1147
Srividya NeelakantanPfizer Inc, Cambridge, Massachusetts, USA.ORCID 0000-0001-8768-414X
Kenichi FurihataP-One Clinic, Keikokai Medical Corporation, Tokyo, Japan.ORCID 0000-0001-7123-1381
Hirotoshi YuasaPfizer R&D Japan, Tokyo, Japan.ORCID 0009-0007-2067-7392
Nanzhi ShiPfizer R&D Japan, Tokyo, Japan.ORCID 0000-0002-8050-9311
Yuichi YamamotoPfizer R&D Japan, Tokyo, Japan.
Kenneth E HungPfizer Inc, Cambridge, Massachusetts, USA.ORCID 0000-0003-3384-4632

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PF-06480605, a fully human IgG1 monoclonal antibody targeting tumor necrosis factor α-like ligand 1A (TL1A), has demonstrated acceptable safety and the potential as an effective treatment for inflammatory bowel disease in phase 1/2a studies. To facilitate future clinical development in Japan and China, a Japan local phase 1 study was designed in consultation with the Japan regulatory authority. In addition to fulfilling Japan regulatory requirements, this study will bring operational efficiency and speed to global and China development by evaluating PF-06480605 in Japanese healthy adults prior to a China local phase 1 study as required by the China regulatory authority. This phase 1, randomized, double-blind, placebo-controlled, single-dose escalating study investigated the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics of PF-06480605 in Japanese healthy adults assigned to receive a single subcutaneous (SC) dose of PF-06480605 150 mg (N = 6), 450 mg (first-in-human dose level, N = 6), or placebo (N = 4). PF-06480605 was well tolerated and absorbed slowly with a median T

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedTumor Necrosis Factor Ligand Superfamily Member 15AdultDose-Response Relationship, DrugDouble-Blind MethodEast Asian PeopleFemaleHealthy VolunteersHumansInjections, SubcutaneousJapanMaleMiddle AgedYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedTNFSF15 protein, humanTumor Necrosis Factor Ligand Superfamily Member 15Chinafirst‐in‐humanfirst‐in‐JapaneseJapanMHLWPF‐06480605pharmacodynamicpharmacokineticPMDATL1A

Identifiers

PMID40065559
PMCPMC11893724

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.