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

Year: 2026
Type: article
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).
Language: English
Subfield: Dermatology
Field: Medicine
Open Access status: gold
Estimated APC paid: $2,000
Funder: Pfizer
OpenAlex ID: W7202139428
FWCI:
Cites: 21
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Related to: 10