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NCT01037543 · ClinicalTrials.gov registry record · Phase 1
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
A Phase 1 study of Healthy, sponsored by Hanmi Pharmaceutical Company Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT01037543: Completed Phase 1 study of Healthy, sponsored by Hanmi Pharmaceutical Company Limited.
NCT01037543 is a Phase 1 study of Healthy that has completed, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 84 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01037543, a Phase 1 study of Healthy, has completed, sponsored by Hanmi Pharmaceutical Company Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Design * Randomized, double-blind, placebo-controlled, escalating single-dose design. * Six ascending dose cohorts * In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control). * Primary Objective * to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.
Conditions Studied
Interventions
- DRUG HM10460A or placebo or Neulasta
Study Locations (1)
California
- - California City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT01037543 record still lists
NCT01037543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which HM10460A or placebo or Neulasta is the first listed.
NCT01037543 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01037543 about?
NCT01037543 is a clinical study titled "Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects". Study Design * Randomized, double-blind, placebo-controlled, escalating single-dose design. * Six ascending dose cohorts * In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control). * Primary Objective * to assess ...
What is the current status of trial NCT01037543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2009-11. Estimated completion is 2011-04.
What conditions does trial NCT01037543 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01037543?
The interventions under investigation include: HM10460A or placebo or Neulasta (DRUG).
Who is sponsoring clinical trial NCT01037543?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01037543 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01037543's enrollment target sits among peer trials
84 267th of 1090 higher than 821 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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