• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Critical Pharma completes second trial on CP024 intranasal growth hormone

Critical Pharma completes second trial on CP024 intranasal growth hormone

February 13, 2013
CenterWatch Staff

Critical Pharmaceuticals, a Nottingham, U.K.-based biotechnology company, has successfully completed a second clinical study on its CP024 growth hormone nasal spray.

The results of the trial in healthy subjects showed that CP024 is safe and well tolerated with pharmacokinetics that are highly reproducible ensuring accuracy and ease of dose titration. CP024 strongly induces the production of insulin-like growth factor (IGF-1), which is the principal mediator of growth hormone activity.  

“As well as providing an attractive alternative to injection, we believe CP024 may have clinical benefits by reducing circulating growth hormone levels which reduce insulin sensitivity seen with current treatments of growth hormone while maintaining therapeutic IGF-1 levels,” said Dr. Gareth King, CEO Critical Pharmaceuticals.

In the clinical trial, six dose levels of CP024 (between 2-6mg growth hormone) were administered to healthy subjects along with an infusion of octreotide to suppress the production of endogenous growth hormone. The objectives of the study were to measure the pharmacokinetics, pharmacodynamics and dose response relationship of CP024 compared to a subcutaneous dose of 0.75mg Omnitrope.

Results confirmed that CP024 was well tolerated and the few adverse events observed were mild and transient and similar to those observed with over the counter marketed nasal products (e.g. Beconase). CP024 pharmacokinetics were also highly reproducible and showed a linear dose response indicating that it would be possible to accurately set and titrate dose in children and adults. Furthermore, the insulin-like growth factor 1 (IGF-1) was strongly induced after dosing with CP024 and is the only reported product to induce therapeutic levels of this important biomarker after intranasal administration.

CP024 is a dry powder formulation of hGH containing CriticalSorb absorption promoter, a best in class nasal absorption promoter, and delivered using an easy to use nasal spray device. CriticalSorb is a marketed pharmaceutical excipient with an extensive toxicology package demonstrating its safety profile. Critical Pharmaceuticals has pending patents in major territories for CriticalSorb and its CP024 nasal growth hormone product.

CP024 has been developed with funding support from the Wellcome Trust.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing