MedTrace Logo

A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes

NCT05693909 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-24

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about SP-420 ability to remove iron from organs in subjects with transfusion-dependent β-thalassemia or transfusion-dependent low-risk myelodysplastic syndrome.

The main questions it aims to answer are:

* How efficient is SP-420 in cleaning iron from the liver?
* How is the safety and tolerability of ascending doses of SP-420?

Participants will:

* Take medication three times weekly
* Attend up to 20 site visits
* Undergo MRI scans

Conditions

Interventions

DRUG

SP-420

Capsules for oral intake

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Pharmacosmos Clinical and non-clinical Department · Pharmacosmos A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2027-10-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases
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 NCT05693909 on ClinicalTrials.gov