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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: Completed Phase 1 study, sponsored by Hanmi Pharmaceutical Company Limited.

NCT01030315 is a Phase 1 study that has completed, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT01030315 record still lists

NCT01030315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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

NCT01030315 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01030315's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01030315, the US trial registry maintained by the National Library of Medicine. NCT01030315 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.