Phase 1 Genotropin Injector Pens Study, Healthy Adults
ClinicalTrials.gov Studies
Summary
NIH registered a Phase 1 clinical trial (NCT07542886) evaluating two injector pen devices for delivering Genotropin (somatropin) in 18-60 year old healthy adults. The 10-week study will compare pharmacokinetic profiles between a marketed Genotropin Pen 12 and a new Genotropin Injector Pen. Adults with BMI 16-32 will receive subcutaneous injections with blood sampling to measure drug uptake.
What changed
NIH added a Phase 1 clinical trial registration for NCT07542886, a pharmacokinetic study comparing a marketed Genotropin Pen 12 with a new Genotropin Injector Pen in healthy adults. The study will enroll adults aged 18-60 with BMI 16-32 and measure blood concentrations of somatropin following subcutaneous injection under each device.
For clinical investigators and trial sponsors, this represents a routine study registration. Sponsors developing injector pen devices for biopharmaceutical delivery may reference this as a regulatory-grade PK comparability benchmark. The GxP framework governing clinical data collection applies to all sites conducting this trial.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults
Phase 1 NCT07542886 Kind: PHASE1 Apr 21, 2026
Abstract
The purpose of this clinical study is to learn about how different injector pens affect:
- how the study medicine (called Genotropin) is delivered into the body and
- how the study medicine is taken up into the blood in healthy adults.
The study is seeking participants who are:
- Aged 18 to 60 years old
- Male or female who are healthy as determined by medical assessment
- Body-mass index (BMI) of 16 to 32, and a total body weight more than 45 kg. BMI is a way to estimate a healthy body weight for an adult's height.
Adults in this study will receive study medicine by a shot under the skin. The study medicine will be given using 2 different injector pens which are medical devices that give a shot under the skin. Blood samples will be taken before and after the shots to look for the study medicine. We will compare the amount of study medicine in the blood between shots from the 2 injector pens.
Adults will take part in this study for about 10 weeks including the screening period. They will have to stay at the study clinic for at least 13 days. This includes 2 study periods in total. A follow up phone call will be made 23 to 30 days following the last study period.
Conditions: Healthy
Interventions: Marketed Genotropin Pen 12, New Genotropin Injector Pen, Genotropin 4mg
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