Pfizer's first-in-human trial of PF-07985631, a biologic in development for IgA nephropathy (IgAN), has been terminated after enrolling 9 participants, according to an update to ClinicalTrials.gov. Pfizer cited an assessment that the candidate's estimated benefit-risk profile was unlikely to be favorable in the target population as the reason for terminating the study.
Pfizer had previously disclosed the discontinuation of PF-07985631 in its pipeline reporting, but had not provided a reason. The ClinicalTrials.gov update now attributes the decision to an unfavorable estimated benefit-risk assessment.
The study (NCT07235150) was a randomized, double-blind, placebo-controlled Phase I single ascending dose trial in healthy adult volunteers conducted in Australia. The design included up to 11 cohorts across seven ascending dose levels, plus optional Japanese and Chinese ethnic subgroups, with a planned enrollment of approximately 88 participants. The registry records actual enrollment at 9 — roughly 10% of the planned figure — before the study was stopped. No results have been posted.
Pfizer classified PF-07985631 as a biologic new molecular entity targeting IgAN, with subcutaneous delivery. The company's pipeline listed the molecule's target as undisclosed.