MedTrace Logo

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

NCT07641634 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-06-18

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers
  • Systemic Sclerosis (SSc)
  • Scleroderma, Systemic
  • Scleroderma

Interventions

DRUG

PRO-203

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

OTHER

Placebo

Matching placebo comparator for Part 1 participants.

Sponsors & Collaborators

  • Prolium Bioscience, Inc

    lead INDUSTRY

Principal Investigators

  • Salim Mujais · Prolium Bioscience, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • Australia
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07641634 on ClinicalTrials.gov