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A Study of JR-141 in Patients With Mucopolysaccharidosis II (BR21)

NCT03359213 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-24

No results posted yet for this study

Summary

A Phase II open-label, randomized, parallel group, 2 sites (Brazil), designed to evaluate the safety and efficacy of 3 doses of study drug for the treatment of the MPS II.

Conditions

  • Mucopolysaccharidosis II

Interventions

DRUG

JR-141

IV infusion (lyophilized powder), 1.0 mg/kg/week

DRUG

JR-141

IV infusion (lyophilized powder), 2.0 mg/kg/week

DRUG

JR-141

IV infusion (lyophilized powder), 4.0 mg/kg/week

Sponsors & Collaborators

  • JCR Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2019-10-04
Completion
2019-10-04

Countries

  • Brazil

Study Locations

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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 NCT03359213 on ClinicalTrials.gov