Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)

June 7, 2010 updated by: Ascendis Pharma A/S

Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)

Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects
  • 20 to 45 years old
  • Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
  • Others

Exclusion Criteria:

  • Known history of hypersensitivity to human growth hormone (hGH)
  • Known history of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, immunological, hepatic or renal disease, or malignancies
  • Others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACP-001, dose-level 1
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 4, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Experimental: ACP-001, dose-level 2
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 4, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Experimental: ACP-001, dose-level 3
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 4, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days
Experimental: ACP-001, dose-level 4
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 1, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 2, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 3, s.c., single-dose
Drug: ACP-001 (TransCon PEG hGH)
ACP-001, dose-level 4, s.c., single-dose
Drug: Placebo
Placebo, s.c., single-dose
Drug: Human Growth Hormone
Human Growth Hormone, s.c., daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability (adverse events, local reactions, immunogenicity)
Time Frame: 0-42 days
0-42 days
Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP
Time Frame: 0-28 days
0-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascendis Pharma A/S

Investigators

  • Study Director: Ascendis Pharma, Ascendis Pharma A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 7, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACP-001 (Prot. 3695)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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