Clinical Trial

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

Recruiting Phase 1/2
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Summary
A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-06-19
critical Phase changed: Phase 1 -> Phase 1/2 2026-06-18
critical Primary endpoint(s) modified 2026-06-18
notable Enrollment reduced: 74 -> 44 participants 2026-06-18
minor Completion pushed: 2027-02 -> 2028-01 2026-06-18
Trial Details
NCT Number NCT07641634
Lead Sponsor Prolium Bioscience, Inc
Conditions Healthy Volunteers, Systemic Sclerosis (SSc), Scleroderma, Systemic, Scleroderma
Enrollment 44 participants
Start Date 2025-10-27
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-18