This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
København Ø, Denmark
Novo Nordisk Investigational Site
Odense, Denmark
Safety and tolerability (adverse events, local tolerability, physical examination)
Time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)
Cmax, maximum concentration of IGF-I
Time frame: after trial product administration
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Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks