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Peer-reviewedCC BY-NC-NDJID innovations : skin science from molecules to population health

A phase 1 study of PF-07242813, an anti-CD1a antibody, in healthy participants and in patients with atopic dermatitis.

  • Spencer I Danto1
  • Ruolun Qiu1
  • Yifan Zhou1
  • Vivek Pradhan1
  • Natalie Rath2
  • Karen M Page3
  • Xingpeng Li1
  • Elena Peeva1
  • Michael S Vincent1
  • Jeremy D Gale4
4 affiliations
  1. 1Research and Development, Pfizer, Cambridge, Massachusetts, USA.
  2. 2Pfizer, Collegeville, Pennsylvania, USA.
  3. 3Translational Clinical Sciences, Pfizer, Cambridge, Massachusetts, USA.
  4. 4Inflammation and Immunology Research Unit, Pfizer, Cambridge, Massachusetts, USA.
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Abstract

Background and aim

PF-07242813 (anti-CD1a) was designed to inhibit T-cell proinflammatory signaling. This analysis evaluated the safety and pharmacokinetics of single ascending doses and multiple ascending doses (MADs) of PF-07242813 in healthy participants and the pharmacodynamics of a single dose in patients with atopic dermatitis (AD).Methods

In part 1, healthy participants (aged 18-55 years) received PF-07242813 intravenously (single ascending doses), subcutaneously (MADs) or intravenously (MADs), or placebo. In part 2, patients with moderate-to-severe AD (aged 18-65 years) were randomized (2:1) to receive 1000 mg PF-07242813 intravenously or placebo. Endpoints included safety and pharmacokinetic outcomes in healthy participants and efficacy endpoints in patients with AD.Results

Of the 122 participants (single ascending doses: n = 57; MADs: n = 40; AD: n = 25), 41 reported treatment-emergent adverse events (mostly mild); headache (4.9%) and alanine transaminase increase (4.9%) were the most common. Peak serum PF-07242813 concentrations occurred at 0.6-2 hours (intravenously, single ascending doses) and 73-169 hours (subcutaneously, MADs). Overall, PF-07242813 did not demonstrate clinical benefit in patients with AD.Conclusions

CD1a blockade is not sufficient to produce a clinical effect in patients with AD. PF-07242813 was well tolerated and may be useful for CD1a pathway analyses. This study is registered at ClinicalTrials.gov (identifier NCT04668066).

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Cite

BibTeXRIS
BibTeX
@article{danto2026phase,
  title = {{A phase 1 study of PF-07242813, an anti-CD1a antibody, in healthy participants and in patients with atopic dermatitis.}},
  author = {Spencer I Danto and Ruolun Qiu and Yifan Zhou and Vivek Pradhan and Natalie Rath and Karen M Page and Xingpeng Li and Elena Peeva and Michael S Vincent and Jeremy D Gale},
  journal = {JID innovations : skin science from molecules to population health},
  year = {2026},
  month = aug,
  doi = {10.1016/j.xjidi.2026.100523},
  url = {https://europepmc.org/article/MED/42921257},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - A phase 1 study of PF-07242813, an anti-CD1a antibody, in healthy participants and in patients with atopic dermatitis.
AU  - Spencer I Danto
AU  - Ruolun Qiu
AU  - Yifan Zhou
AU  - Vivek Pradhan
AU  - Natalie Rath
AU  - Karen M Page
AU  - Xingpeng Li
AU  - Elena Peeva
AU  - Michael S Vincent
AU  - Jeremy D Gale
PY  - 2026
DA  - 2026/08/10
JO  - JID innovations : skin science from molecules to population health
DO  - 10.1016/j.xjidi.2026.100523
UR  - https://europepmc.org/article/MED/42921257
AB  - Background and aim  PF-07242813 (anti-CD1a) was designed to inhibit T-cell proinflammatory signaling. This analysis evaluated the safety and pharmacokinetics of single ascending doses and multiple ascending doses (MADs) of PF-07242813 in healthy participants and the pharmacodynamics of a single dose in patients with atopic dermatitis (AD).Methods  In part 1, healthy participants (aged 18-55 years) received PF-07242813 intravenously (single ascending doses), subcutaneously (MADs) or intravenously (MADs), or placebo. In part 2, patients with moderate-to-severe AD (aged 18-65 years) were randomized (2:1) to receive 1000 mg PF-07242813 intravenously or placebo. Endpoints included safety and pharmacokinetic outcomes in healthy participants and efficacy endpoints in patients with AD.Results  Of the 122 participants (single ascending doses: n = 57; MADs: n = 40; AD: n = 25), 41 reported treatment-emergent adverse events (mostly mild); headache (4.9%) and alanine transaminase increase (4.9%) were the most common. Peak serum PF-07242813 concentrations occurred at 0.6-2 hours (intravenously, single ascending doses) and 73-169 hours (subcutaneously, MADs). Overall, PF-07242813 did not demonstrate clinical benefit in patients with AD.Conclusions  CD1a blockade is not sufficient to produce a clinical effect in patients with AD. PF-07242813 was well tolerated and may be useful for CD1a pathway analyses. This study is registered at ClinicalTrials.gov (identifier NCT04668066).
SN  - 2667-0267
ER  -