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A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum

NCT05569252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-12-31

Study results available
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Summary

This study was designed to evaluate the safety, tolerability, pharmacodynamics (PD) of DS-1211b, and pharmacokinetics (PK) in individuals with Pseudoxanthoma elasticum (PXE). PXE is a rare disease that is associated with significant risks of visual impairments and comorbidity from peripheral and cardiovascular diseases, and adversely impacts the quality of life in afflicted individuals.

Conditions

  • Pseudoxanthoma Elasticum

Interventions

DRUG

DS-1211b

DS-1211b tablet administered once daily in the morning either in the fasted state or with a meal

OTHER

Placebo

Placebo tablet administered once daily in the morning either in the fasted state or with a meal

Sponsors & Collaborators

Principal Investigators

  • Clinical Director · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-11-21
Completion
2023-11-21
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT05569252 on ClinicalTrials.gov