Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034202

Enrollment

Registered

2009-12-17

Start date

2007-08-31

Completion date

2008-01-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Disorder, Healthy

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

Interventions

DRUGNNC126-0083

One of five dose levels administered subcutaneously (under the skin)

DRUGNorditropin® SimpleXx®

One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin)

DRUGplacebo

Placebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, non-smoking male subjects * Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive * Body weight max. 100 kg

Exclusion criteria

* A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases * Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies * Positive result of test for HIV (Human Immunodeficiency Virus) antibodies * Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician * Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician * A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits) * Habitual smoking, i.e daily smoking or more than 7 cigarettes/week * Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial * Surgery or trauma with significant blood loss within the last 2 months prior to dosing

Design outcomes

Primary

Measure	Time frame
Number of adverse events	after administration of a single dose of NNC126-0083

Secondary

Measure	Time frame
Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083	0-168 hours after trial drug administration
Number of injection site reactions	after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®
IGF-I (Insulin-like Growth Factor I) levels	after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026