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

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 Overview

• Status: Completed
• Conditions: Healthy; Growth Hormone Disorder; Growth Hormone Deficiency in Children; Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: somapacitan; Drug: placebo (somapacitan)

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose (SD); Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation	Drug: somapacitan; Administered s.c. (subcutaneously, under the skin); Other Names: NNC0195-0092; Drug: placebo (somapacitan); Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)
Experimental: Multiple dose (MD); 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	Drug: somapacitan; Administered s.c. (subcutaneously, under the skin); Other Names: NNC0195-0092; Drug: placebo (somapacitan); Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)	From 0-240 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 40 (SD part)
Number of injection site reactions	From first administration of trial product and up until day 49 (MD part)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
• Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
• Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2012
• Primary Completion (Actual): March 18, 2013
• Study Completion (Actual): March 18, 2013

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Endocrine System Diseases
• Other Study ID Numbers: NN8640-3915; U1111-1119-0539 (Other Identifier: WHO); 2011-000146-38 (EudraCT Number)