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A Study Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124 in Adults With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome

NCT04718844 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-01-03

No results posted yet for this study

Summary

This study will investigate the safety and tolerability of SLN124 in patients with Thalassaemia or patients with Very Low- and Low-risk Myelodysplastic Syndrome (MDS) after single ascending s.c. doses and multiple doses in healthy male and female subjects. Up to 7 cohorts of 56 patients with Thalassaemia and up to 7 cohorts of 56 patients with MDS will be enrolled. Each subject will receive single or multiple doses of SLN124 or placebo given by subcutaneous (s.c) injection.

Conditions

  • Non-transfusion-dependent Thalassemia
  • Low Risk Myelodysplastic Syndrome
  • Very-Low Risk Myelodysplastic Syndrome

Interventions

DRUG

SLN124

SLN124 for subcutaneous (s.c.) injection

DRUG

Placebo

Sodium chloride for s.c. injection

Sponsors & Collaborators

  • Silence Therapeutics plc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2023-05-23
Completion
2023-05-23
FDA Drug
Yes

Countries

  • Germany
  • Israel
  • Italy
  • Jordan
  • Malaysia
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04718844 on ClinicalTrials.gov