A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-07261271 in healthy participants - PubMed
4 hours ago
- #bispecific-antibody
- #phase-1-trial
- #inflammatory-bowel-disease
- PF-07261271 is a bispecific antibody targeting p40 (IL-12/23 subunit) and TL1A, studied as a potential IBD therapy.
- A phase 1 randomized, double-blind, placebo-controlled trial evaluated single ascending doses (30-1000 mg IV) and multiple doses (300 mg SC every 4 weeks) in healthy adults.
- PF-07261271 was generally safe and well-tolerated, with all adverse events being mild to moderate.
- Pharmacokinetics showed a multi-phase decline post-peak and increased terminal half-life at higher doses; subcutaneous bioavailability was 48%.
- Dose-dependent increases in serum total sTL1A and p40 demonstrated target engagement, with no significant impact from anti-drug antibodies.
- The study supports further evaluation of PF-07261271 for safety and efficacy in IBD patients.