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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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