Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-11 @ 4:43 PM
Study NCT ID:
NCT01034202
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2009-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-001255-19 | EUDRACT_NUMBER | None | View |