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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.

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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

FieldValue
Enrollment Target 42 participants
Start Date 2015-01
Est. Completion 2015-06
Phase Phase 1

Sponsor

OPKO Health

32 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.