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

NCT01010425 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-06-08

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Ascendis Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Ascendis Pharma · Ascendis Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-02-28
Completion
2010-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT01010425 on ClinicalTrials.gov