This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
0.1 mg once weekly, s.c. injection
0.2 mg once weekly, s.c. injection
0.4 mg once weekly, s.c. injection
Unnamed facility
London Southwest, United Kingdom
Adverse events
Time frame: at all scheduled visits (2 - 14) following screening
Frequency of hypoglycaemic episodes
Time frame: at all scheduled visits (2 - 14) following screening
Vital signs (blood pressure and pulse)
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
12-lead ECG (electrocardiogram)
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Haematology
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Biochemistry
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Urinalysis
Time frame: at all scheduled visits (2 - 14) including screening (visit 1)
Calcitonin
Time frame: at screening (visit 1) and at visits 2, 9 and 14
Antibody development against N9535
Time frame: at visits 2 and 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection
0.1 mg once weekly, s.c. injection
0.2 mg once weekly, s.c. injection
0.4 mg once weekly, s.c. injection
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection