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Completed

NCT Number: NCT01010425

Pharmacokinetics and Pharmacodynamics 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).

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACP-001 (TransCon PEG hGH)

Drug

ACP-001, dose-level 1, s.c., single-dose

Placebo

Drug

Placebo, s.c., single-dose

Human Growth Hormone

Drug

Human Growth Hormone, s.c., daily for 7 days

Primary outcomes

  1. Safety and Tolerability (adverse events, local reactions, immunogenicity)

    Time frame: 0-42 days

  2. Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP

    Time frame: 0-28 days

Sponsors and collaborators

Lead sponsor

Ascendis Pharma A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 10, 2009
Registry last updated
Jun 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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