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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: Completed Phase 1 study of Growth Hormone Deficiency, sponsored by OPKO Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the safety, tolerability and immunogenicity of MOD-4023 in healthy Caucasian and Japanese subjects after single subcutaneous (SC) dose.
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 |
What the finished NCT02418767 record still lists
NCT02418767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 385-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Growth Hormone Deficiency
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 NCT02418767's enrollment target sits among peer trials
42 8th of 16 higher than 8 of 16 other Growth Hormone Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Growth Hormone Deficiency 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.
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