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Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

NCT05019742 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-06-26

Study results available
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Summary

SPH3127-US-01 is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of SPH3127 for the treatment of mild-to-moderate ulcerative colitis.

Conditions

Interventions

DRUG

SPH3127

SPH3127 - selective renin inhibitor

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shanghai Pharma Biotherapeutics USA Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth W. Locke, PhD · Shanghai Pharma Biotherapeutics USA Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT05019742 on ClinicalTrials.gov