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NCT01030315 · ClinicalTrials.gov registry record · Phase 1

A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects

A Phase 1 study, sponsored by Hanmi Pharmaceutical Company Limited.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT01030315 is a Phase 1 study that has completed, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 65 participants.

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The verdict

NCT01030315, a Phase 1 study, has completed, sponsored by Hanmi Pharmaceutical Company Limited.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

Study design: * Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be randomized to receive a single dose of HM10760A or placebo. Primary Objective: * To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.

Interventions

  • DRUG HM10760A or placebo

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2009-10
Est. Completion 2011-01
Phase Phase 1

What the Registry Record Tells You About NCT01030315

The ClinicalTrials.gov registry entry for NCT01030315 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which HM10760A or placebo is the first listed.

NCT01030315 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01030315 about?

NCT01030315 is a clinical study titled "A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects". Study design: * Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be random...

What is the current status of trial NCT01030315?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2009-10. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01030315?

The interventions under investigation include: HM10760A or placebo (DRUG).

Who is sponsoring clinical trial NCT01030315?

This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.