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NCT02418767 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers
A Phase 1 study of Growth Hormone Deficiency, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT02418767 is a Phase 1 study of Growth Hormone Deficiency that has completed, run by OPKO Health. The registered enrollment target is 42 participants, below the 385-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02418767, a Phase 1 study of Growth Hormone Deficiency, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers. Following a 4-week screening period, eligible male subjects will be stratified by ethnic group and will be randomized to one of six groups. On dosing day, designated as Day 1, each subject will receive single SC injection of study medication according to group allocation and will be followed up for a month for safety monitoring.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MOD-4023
Study Locations (1)
California
- WCCT Global - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02418767
The ClinicalTrials.gov registry entry for NCT02418767 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 385-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (89% lower). The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02418767 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02418767 about?
NCT02418767 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers". The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers. Following a 4-week screening period, eligible male subjects will be stratified by ethnic group and will be randomized to one of six groups. O...
What is the current status of trial NCT02418767?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2015-01. Estimated completion is 2015-06.
What conditions does trial NCT02418767 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency.
What interventions are being tested in trial NCT02418767?
The interventions under investigation include: Placebo (DRUG), MOD-4023 (DRUG).
Who is sponsoring clinical trial NCT02418767?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02418767 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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