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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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
Neuss, Germany
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: 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)
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Dose level 3 repeated; NNC126-0083 placebo for 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 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks