RecruitingPhase 1Phase 2NCT07641634

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

A Two-part, Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study of PRO-203 in Healthy Adult Volunteers Followed by an Open-label, Single-ascending-dose With Priming Study of PRO-203 in Participants With Systemic Sclerosis

Sponsor

Prolium Bioscience, Inc

Enrollment

44 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Scleroderma Systemic Sclerosis (SSc)Scleroderma, Systemic

Summary

A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PRO-203 and Placebo for people with healthy volunteers, scleroderma, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRO-203

PRO-203 administered as escalating single dose in healthy participants or as a single cycle in participants with systemic sclerosis.

OTHERPlacebo

Matching placebo comparator for Part 1 participants.

Locations(11)

Nucleus Network

Melbourne, Victoria, Australia

Peking University Third Hospital

Beijing, China

Guangdong Provincial People's Hospital

Guangzhou, China

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

Pingxiang People's Hospital

Pingxiang, China

Hospital Angeles Chihuahua

Chihuahua City, Mexico

Unidad Médica para la Salud Integral (UMSI)

San Nicolás de los Garza, Mexico

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07641634

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