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

Phase 1

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children; Healthy
• Interventions: Drug: somapacitan; Drug: placebo (somapacitan)

• Registration Number: NCT01514500
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-13
• Study Start: 2012-01-16
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2013-03-18
• Study Completion: 2013-03-18
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple dose (MD)	somapacitan	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
Single dose (SD)	placebo (somapacitan)	Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation
Multiple dose (MD)	placebo (somapacitan)	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
Single dose (SD)	somapacitan	Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (Single Dose)	From first administration of trial product and up until day 40
Incidence of adverse events (Multiple Dose)	From first administration of trial product and up until day 49

Secondary Outcome Measures

Name	Time	Method
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve	From 0 to 168 hours
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)	up to day 40
Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan)	up to day 40
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve	From 0-168 hours
Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only)	From 0-240 hours
Maximum serum concentration (Cmax) for IGF-I	up to day 40
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve	From 0-168 hours
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only)	From 0-240 hours
Maximum serum concentration (Cmax) for IGFBP-3	up to day 40
Number of injection site reactions	From first administration of trial product and up until day 49 (MD part)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany