Evidence map›Paper›PMID 42235928›Full record

Trial reportBritish journal of clinical pharmacology2026

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-07261271 in healthy participants.

Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons-Rich, Grace Lee, Bryce G Johnson, Elena Peeva and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05536440 (A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE INTRAVENOUS AND MULTIPLE SUBCUTANEOUS AND INTRAVENOUS DOSES OF PF-07261271 IN HEALTHY PARTICIPANTS), which is not on this 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.

NCT05536440 phase1completednot on this map

A phase 1, randomized, double-blind, sponsor open, placebo controlled, dose escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous and multiple subcutaneous and intravenous doses of pf-07261271 in healthy participants

TypeinterventionalSponsorPfizerRan2022 to 2024Enrolled35ConditionsHealthyArmsPF-07261271, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Interleukin-23 Inhibitors in Inflammatory Bowel Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    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

12 authors.

Srividya NeelakantanPfizer Inc, Cambridge, MA, USA.
Christopher BanfieldPfizer Inc, Cambridge, MA, USA.
Kenneth HungPfizer Inc, Cambridge, MA, USA.
Anna SaponePfizer Inc, Cambridge, MA, USA.
Vivek PradhanPfizer Inc, Cambridge, MA, USA.
Yuxi ZhaoPfizer Inc, Cambridge, MA, USA.
Dana Parsons-RichPfizer Inc, Cambridge, MA, USA.
Grace LeePfizer Inc, New York, NY, USA.
Bryce G JohnsonPfizer Inc, Cambridge, MA, USA.
Elena PeevaPfizer Inc, Cambridge, MA, USA.
Michael S VincentPfizer Inc, Cambridge, MA, USA.
Valerie M ClerinPfizer Inc, Cambridge, MA, USA.

Funding

Pfizer
6 · The paper itself

Abstract

aimThere is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF-07261271, a bispecific antibody targeting both the p40 subunit of interleukin-12/23 and tumour necrosis factor-like cytokine 1A (TL1A), is being investigated as a potential new IBD therapy. This study evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-07261271 in healthy participants.

methodsThis phase 1, randomized, double-blind, placebo-controlled study assessed single ascending doses (SAD; intravenous 30-1000 mg) and multiple doses (MD; subcutaneous 300 mg once every 4 weeks) of PF-07261271 in healthy adults. Safety, PK, immunogenicity and exploratory PD serum biomarkers (total soluble TL1A [sTL1A] and p40) were evaluated.

resultsThirty-five participants were enrolled (Part A: SAD, N = 27; Part B: MD, N = 8). PF-07261271 was generally safe and well tolerated; all treatment-emergent adverse events were mild/moderate. Following peak serum concentration, there was a multi-phase decline with a trend towards increased terminal half-life at the higher doses. For the MD cohort, the estimated bioavailability of PF-07261271 administered subcutaneously was 48%. Dose-dependent increases from baseline in serum total sTL1A and p40 levels were observed in participants receiving PF-07261271, demonstrating target engagement. There was no apparent impact of anti-drug antibodies on safety, PK or PD parameters.

conclusionPF-07261271 demonstrated p40 and TL1A target engagement and a favourable safety profile. Further studies are warranted to evaluate its safety and efficacy in patients with IBD. CLINICALTRIALS: gov: NCT05536440.

Indexed as

Antibodies, BispecificAdolescentAdultDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansInjections, SubcutaneousInterleukin-12 Subunit p40MaleMiddle AgedTumor Necrosis Factor Ligand Superfamily Member 15Young AdultAntibodies, BispecificInterleukin-12 Subunit p40Tumor Necrosis Factor Ligand Superfamily Member 15bispecific antibodyinflammatory bowel diseasep40TL1A

Identifiers

PMID42235928
PMCPMC13619095

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.