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

NCT01247675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-03-09

Study results available
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Summary

This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.

Conditions

  • Adult Growth Hormone Deficiency

Interventions

DRUG

ACP-001 (TransCon hGH)

s.c., weekly injection

DRUG

ACP-001 (TransCon hGH)

s.c., weekly injection

DRUG

ACP-001 (TransCon hGH)

s.c., weekly injection

DRUG

Omnitrope

s.c., daily injection

Sponsors & Collaborators

  • Ascendis Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Michael Beckert, MD · Ascendis Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Denmark
  • Germany
  • Italy
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01247675 on ClinicalTrials.gov