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

NCT07542886 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: A62813312026-525165-52-00
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

bioequivalence; genotropin; adult

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

  At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period

• Maximum Observed Plasma Concentration (Cmax) for Somatropin

  At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events

  From start of study treatment up to 28-35 days after last dose of study treatment (41 days)

• Number of Participants With Clinical Laboratory Abnormalities

  Up to Day 11

• Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast)

  At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period

• Maximum observed effect (Emax)

  At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period

Study Arms (2)

Sequence 1

EXPERIMENTAL

Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test)

Device: Marketed Genotropin Pen 12; Device: New Genotropin Injector Pen; Drug: Genotropin 4mg

Sequence 2

EXPERIMENTAL

Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference)

Device: Marketed Genotropin Pen 12; Device: New Genotropin Injector Pen; Drug: Genotropin 4mg

Interventions

Marketed Genotropin Pen 12 DEVICE

Growth Hormone Delivery Device for use with Somatropin for injection

Sequence 1; Sequence 2

New Genotropin Injector Pen DEVICE

Growth Hormone Delivery Device for use with Somatropin for injection

Sequence 1; Sequence 2

Genotropin 4mg DRUG

4mg subcutaneous

Also known as: Somatropin

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share