Phase I Trial of Subcutaneous VDJ010 In Healthy Subjects and Patients With Ulcerative Colitis

This study is a first-in-human, Phase I, multi-center, double-blind, placebo-controlled, single- and multiple-ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered VDJ010 (recombinant human fusion protein) in two parts: Part A enrolls 28 healthy subjects across four single-dose cohorts (500K, 750K, 1,000K, and 1,250/1,500K IU), and Part B enrolls 20 patients with moderately to severely active ulcerative colitis across three multiple-dose cohorts (750K, 1,000K, and 1,250/1,500K IU) dosed subcutaneously every two weeks for a total of three doses. The primary objective is to assess safety and tolerability, while secondary objectives include characterizing PK profiles, immunogenicity (ADA/NAB), and PD effects measured by changes in peripheral blood Treg, Tcon, NK, and B cell subsets. Exploratory efficacy endpoints in UC patients include clinical response and remission rates based on modified Mayo score, endoscopic remission, UCEIS score, IBDQ quality of life, and biomarkers such as CRP and fecal calprotectin at Week 8. Dose escalation follows predefined safety stopping criteria with review intervals between cohorts, and all safety assessments are conducted per CTCAE V6.0 through 43 days (healthy) or 57 days (UC) of follow-up.