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

Novo Nordisk A/S105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Growth Hormone Deficiency in Children Healthy

Interventions

somapacitanDRUG

Administered s.c. (subcutaneously, under the skin)

placebo (somapacitan)DRUG

Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Neuss, Germany

Outcomes

Primary Outcomes

Incidence of adverse events (Single Dose)

Time frame: From first administration of trial product and up until day 40

Incidence of adverse events (Multiple Dose)

Time frame: From first administration of trial product and up until day 49

Secondary Outcomes

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve

Time frame: From 0 to 168 hours

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)

Time frame: From 0-240 hours

Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)

Time frame: up to day 40

Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)

Time frame: up to day 40

Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve

Time frame: From 0-168 hours

Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)

Time frame: From 0-240 hours

Maximum serum concentration (Cmax) for IGF-I

Time frame: up to day 40

Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve

Time frame: From 0-168 hours

Data from ClinicalTrials.gov

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