Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT03144271
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    A single dose of 0.625, 1.25, 2.5, 5, 10, 20, 40 or 80 μg/kg semaglutide will be administered subcutaneously (s.c. under the skin).
  • Placebo — DRUG
    A single dose of placebo will be administered subcutaneously (s.c. under the skin)

Study Details

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability of ascending single s.c. doses of NNC 0113-0217 in healthy male subjects, aiming at establishing the Maximum Tolerated Dose (MTD)

Key Dates

Start date
Jun 11, 2007
Status verified
May 2017
Primary completion
Oct 8, 2007
Completion
Oct 8, 2007

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC 0113-0217
    Dose-escalation trial
  • Placebo Comparator: Placebo
    Dose-escalation trial

Primary Outcome Measure

Number of Adverse Events [ Time Frame: After 24-33 days ]

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