Phase 12 Study Evaluating PRO-203 Injection in Healthy Adults and Adults With Systemic Sclerosis

What this Trial Is About

Researchers are evaluating PRO-203, a drug administered subcutaneously, in adult healthy volunteers and participants with Systemic Sclerosis SSc. This two-part Phase 12 study aims to understand the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRO-203 across increasing dose levels. The study includes healthy adults and adults with Systemic Sclerosis who meet specific disease criteria and treatment history. In Part 1, 20 healthy volunteers have completed a single subcutaneous dose of PRO-203 or placebo across dose escalation cohorts. Part 2 will enroll up to 24 participants with Systemic Sclerosis, who will receive a single treatment cycle of PRO-203, with optional additional treatment in a long-term extension phase if retreatment criteria are met. Each participants total involvement may last up to 53 weeks. Participants will undergo regular safety monitoring including assessments of adverse events and lab tests over 13 weeks for healthy volunteers and 49 weeks for Systemic Sclerosis participants. Researchers will also measure drug levels, immune responses, and biomarkers related to PRO-203. The study includes physical exams, ECG, laboratory evaluations, and tracking of symptoms and disease progression throughout the study duration.

A Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.