RecruitingPhase 1NCT07542886

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

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO DIFFERENT INJECTOR PEN DEVICES FOLLOWING SUBCUTANEOUS ADMINISTRATION OF THE SAME GENOTROPIN® (SOMATROPIN) DOSE IN HEALTHY ADULT PARTICIPANTS


Sponsor

Pfizer

Enrollment

26 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • Healthy Participants
  • BMI 16 to 32 kg/m2
  • body weight more than 45kg

Exclusion Criteria4

  • Ongoing or past history of significant medical conditions
  • Use of prescription or non prescription medications within 14 days of first study dose
  • Previous exposure to growth hormone
  • History of alcohol abuse, binge drinking or illicit drug use

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Interventions

DEVICEMarketed Genotropin Pen 12

Growth Hormone Delivery Device for use with Somatropin for injection

DEVICENew Genotropin Injector Pen

Growth Hormone Delivery Device for use with Somatropin for injection

DRUGGenotropin 4mg

4mg subcutaneous


Locations(1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, Belgium

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NCT07542886


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