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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Drug: placebo (somapacitan); Drug: somapacitan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01514500

NN8640-3915

2011-000146-38 (EudraCT Number)

U1111-1119-0539 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Single dose (SD)

Experimental group

Description:

Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation

Treatment:

Drug: placebo (somapacitan)

Drug: somapacitan

Multiple dose (MD)

Experimental group

Description:

Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation

Treatment:

Drug: placebo (somapacitan)

Drug: somapacitan