Announcement of Initiation of First-in-Human Phase I Clinical Trial for TSP-101

Tokyo, Japan – December 15, 2025 – Tensegrity Pharma Inc. (“Tensegrity Pharma”), a biotechnology start-up headquartered in Tokyo, today announced that the first subject has been successfully dosed (First-Subject-In) in its Phase I company-sponsored clinical trial of TSP-101 in Japan.

This first-in-human study is a single ascending dose trial in healthy adult volunteers. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics (PK) of TSP-101. In addition, the trial will estimate receptor occupancy (RO) and explore potential pharmacodynamic and translational biomarkers.

​TSP-101 is Tensegrity Pharma’s first fully human monoclonal antibody targeting Fn14. By inhibiting Fn14 signaling, TSP-101 is being developed with the aim of modulating cancer cachexia and a range of inflammatory diseases driven by this pathway.

Press release (Japanese only)
​https://prtimes.jp/main/html/rd/p/000000003.000152661.html