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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01514500

Enrollment

105

Registered

2012-01-23

Start date

2012-01-16

Completion date

2013-03-18

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGsomapacitan

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

DRUGplacebo (somapacitan)

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

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

Measure	Time frame
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 NNC0195-0092 (somapacitan) serum concentration-time curve	From 0 to 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)
Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve	From 0-168 hours
Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only)	From 0-240 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026