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

StatusRecruiting
PhasePhase 1/2
Started2025-10-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v3
Trial sites expanded: 3 → 11 locations
2026-06-16
Study Status, Outcome Measures v2
Primary endpoint(s) modified1 entry, revised
WasSafety and Tolerability
NowIncidence of Adverse Events and Laboratory Abnormalities [Safety and Tolerability]
Phase changed: Phase 1 → Phase 1/2
Primary endpoint(s) modified9 to 1 entries
WasNumber of participants with TEAEs (Part 2 SSc, Long-term Extension), Number of participants with TESAEs (Part 2 SSc, Long-term Extension), Number of participants with clinically significant changes in 12-lead ECG parameters, Number of participants with clinically significant changes in clinical laboratory values, Number of participants with clinically significant changes in clinical laboratory values or vital signs (Part 2 SSc, Long-term Extension), Number of participants with clinically significant changes in vital signs, Number of participants with dose-limiting toxicities (DLTs), Number of participants with treatment-emergent adverse events (TEAEs), Number of participants with treatment-emergent serious adverse events (TESAEs).
NowSafety and Tolerability
Enrollment reduced: 74 → 44 participants
Completion pushed: 2027-02 → 2028-01
2026-06-14
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
PhasePhase 1→Phase 1/2
Completion date2027-02→2028-01
Enrollment target74→44
Study sites2→3
Eligibility criteria+46 characters
[...] B cell count > 25 cells/uL. Additional Inclusion for Part 1 (Closed to Enrollment) In good general health, determined by no clinically signifi [...] t stay, are allowed Additional Exclusion Criteria for Part 1 (Closed to Enrollment) Use of any prescription medication within 14 days and OTC m [...]
Secondary endpoints16 to 3 entries
Maximum Serum Concentration (Cmax)Pharmacokinetics of PRO-203 TimePharmacodynamic-related to Maximum Serum Concentration (Tmax)biomarkers of PRO-203 Area Under the Serum Concentration-Time Curve (AUC)Immunogenicity of PRO-203 Systemic Clearance of PRO-203 Elimination Half-Life (t1/2) of PRO-203 Change from Baseline in Peripheral Blood B Cell Counts Change from Baseline in Peripheral Blood T Cell Counts Incidence of Anti-Drug Antibodies (ADA) to PRO-203 Maximum Serum Concentration (Cmax) of PRO-203 Post-Retreatment Time [...]
Primary endpoints9 to 1 entries
NumberSafety ofand participants with TEAEs (Part 2 SSc, Long-term Extension) Number of participants with TESAEs (Part 2 SSc, Long-term Extension) Number of participants with clinically significant changes in 12-lead ECG parameters Number of participants with clinically significant changes in clinical laboratory values [...] Tolerability
Study description-36 characters
[...] oss ascending dose levels. Part 1 - Healthy Volunteers (HV) UpPart to1 5enrollment cohortsis (withcomplete upand tohas 2enrolled additional optional cohorts) of approximately 5-1020 healthy adultsvolunteers peracross cohort3 will be enrolledcohorts. Participants within each cohort will receivereceived a single SC dose of PRO-203 or matching placebo. Part 1 has completed enrollment. Part 2 - Systemic Sclerosis (SSc) Up to 24 participants with SSc will be enrolled in 3multiple cohorts (with optional additional cohorts). Each Participants within each cohort will receive a single SC cycle consists [...] [...]
Study title-66 characters
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.
2026-06-07
Original filing
A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).
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 2026-09-08