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

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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

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

Number of Arms

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

Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5.

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.

Clinical Trials on Healthy

Prevent Age Resort "Pervaya Liniya"

Recruiting

First Line Prevent Age Study (FLIPS)

Healthy Aging | Healthy Diet | Healthy Lifestyle

Russian Federation
Maastricht University Medical Center

Completed

Reference Gait Data for Healthy Subjects

Healthy Volunteers | Healthy Subjects | Healthy Adults

Netherlands
Yale University

Not yet recruiting

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

Healthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol

United States
Hasselt University

Recruiting

Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults

Healthy | Healthy Aging

Belgium
Galera Therapeutics, Inc.
Syneos Health

Completed

A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
Galera Therapeutics, Inc.
Syneos Health

Completed

A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
University of Pennsylvania

Active, not recruiting

The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions

Healthy | Healthy Aging

United States
Chalmers University of Technology
Göteborg University

Completed

Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein

Healthy | Nutrition, Healthy

Sweden
Lancaster University

Recruiting

Speed of Absorption

Healthy | Nutrition, Healthy

United Kingdom
University of Manitoba

Not yet recruiting

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

Healthy | Healthy Diet

Clinical Trials on ACP-001 (TransCon PEG hGH)

Ascendis Pharma A/S

Completed

A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency

Adult Growth Hormone Deficiency

Sweden, Denmark, Germany, Italy
Visen Pharmaceuticals (Shanghai) Co., Ltd.
Ascendis Pharma A/S

Unknown

Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency

Endocrine System Diseases | Pituitary Diseases | Growth Hormone Deficiency | Hormones | Pituitary Disease, Anterior

China
Ascendis Pharma A/S

Completed

A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial (enliGHten)

Endocrine System Diseases | Pituitary Diseases | Hormone Deficiency | Growth Hormone Deficiency, Pediatric

United States, Armenia, Belarus, Bulgaria, Georgia, Greece, Russian Federation, Ukraine, Australia, New Zealand, Poland
Ascendis Pharma Endocrinology Division A/S

Completed

A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency

Endocrine System Diseases | Pituitary Diseases | Hormone Deficiency | Growth Hormone Deficiency, Pediatric

United States, Canada, Australia, New Zealand
Ascendis Pharma Endocrinology Division A/S

Completed

A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Endocrine System Diseases | Pituitary Diseases | Hormones | Growth Hormone Deficiency, Pediatric | hGH (Human Growth Hormone)

United States, Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russian Federation, Turkey, Ukraine
Ascendis Pharma A/S

Terminated

A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers

Healthy Volunteers
United Therapeutics

Withdrawn

Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male Volunteers

PAH

United States
Neuraptive Therapeutics Inc.

Active, not recruiting

Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

Peripheral Nerve Injuries

United States
Ascendis Pharma A/S

Completed

Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Growth Hormone Deficiency (GHD)

Egypt, Turkey, Germany, Poland, France, Hungary, Russian Federation, Ukraine, Belarus, Bulgaria, Czech Republic, Greece, Romania, Slovenia
Acerta Pharma BV

Completed

A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants

Healthy Participants

United States

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on ACP-001 (TransCon PEG hGH)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations