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

NCT03144271 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and effects of different doses of the experimental drug NNC 0113-0217, given as a single injection under the skin, in healthy adult men.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 58 people

Who can join Ages 18–65 · male only Healthy volunteers accepted.

Timeline Started 2007-06 · est. completion 2007-10

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT03144271 ↗

Description as written by the study sponsor.

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)

Treatments tested

semaglutide also known as NNC 0113-0217 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)

Main thing measured	Number of Adverse Events
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2, Healthy
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03144271 ↗