Completed PHASE1 INTERVENTIONAL 4-arm NCT03013439

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

Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia

Sponsor: Pharmacosmos A/S

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

Interventions Iron Isomaltoside

Updated 6 times since 2017 Last updated: Dec 8, 2017 Started: Jan 6, 2017 Primary completion: Jun 4, 2017 Completion: Jun 4, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03013439, this PHASE1 trial focuses on Anemia and Anemia, Iron Deficiency and remains completed. Sponsored by Pharmacosmos A/S, it has been updated 6 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Dec 2017 — Jun 2018 [monthly]

Completed PHASE1

Status: Recruiting → Completed

▶ Show 1 earlier version

Feb 2017 — Dec 2017 [monthly]

Recruiting PHASE1

First recorded

Jan 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pharmacosmos A/S

Data source: Pharmacosmos A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Tokyo, Japan