First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

• Status: Completed
• Trial end date: 2013-03-18
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Healthy, non-smoking male subjects

• BMI (body mass index) between 18.0 and 28.0 kg/m^2, both incl.

• Body weight 50 to 100 kg, both incl.

Exclusion Criteria:

• Strenuous exercise within 4 days prior to dosing

• Receipt of any investigational medicinal product within 3 months prior to randomisation