Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

NCT03013439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-12-12

No results posted yet for this study

Summary

The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

Conditions

  • Anemia
  • Deficiency Diseases
  • Anemia, Iron Deficiency
  • Hematologic Disease
  • Iron Metabolism Disorders

Interventions

DRUG

Iron Isomaltoside

The trial is a dose escalating trial.

Sponsors & Collaborators

  • Pharmacosmos A/S

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2017-06-04
Completion
2017-06-04

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT03013439 on ClinicalTrials.gov