Growth Hormone Disorder, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.
Interventions
DRUGNNC126-0083
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
DRUGplacebo
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects with Japanese passport and Japanese born parents * Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive * Subjects must be in good health according to age
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 * History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject * Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (adverse events, local tolerability, physical examination) | 0 to 10 days after third dosing, (day 15-25 after first dose) |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, maximum concentration of IGF-I | 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose) |
Countries
Germany
Outcome results
None listed