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CompletedNCT01010425Updated Jun 8, 2010

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

A Phase 1 interventional study of ACP-001 (TransCon PEG hGH) and ACP-001 (TransCon PEG hGH) in Healthy, sponsored by Ascendis Pharma A/S. Completed at 1 site in Canada. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-08.

Sponsored by Ascendis Pharma A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

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).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Ascendis Pharma A/S is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    ACP-001, dose-level 1

    Drug: ACP-001 (TransCon PEG hGH) · Drug: Placebo · Drug: Human Growth Hormone

  • Experimental
    ACP-001, dose-level 2

    Drug: ACP-001 (TransCon PEG hGH) · Drug: Placebo · Drug: Human Growth Hormone

  • Experimental
    ACP-001, dose-level 3

    Drug: ACP-001 (TransCon PEG hGH) · Drug: Placebo · Drug: Human Growth Hormone

  • Experimental
    ACP-001, dose-level 4

    Drug: ACP-001 (TransCon PEG hGH) · Drug: Placebo · Drug: Human Growth Hormone

Interventions

  • DrugACP-001 (TransCon PEG hGH)

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

  • DrugACP-001 (TransCon PEG hGH)

    ACP-001, dose-level 2, s.c., single-dose

  • DrugACP-001 (TransCon PEG hGH)

    ACP-001, dose-level 3, s.c., single-dose

  • DrugACP-001 (TransCon PEG hGH)

    ACP-001, dose-level 4, s.c., single-dose

  • DrugPlacebo

    Placebo, s.c., single-dose

  • DrugHuman Growth Hormone

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

06

What researchers measure

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

07

Study locations

1 site
  • Toronto, Ontario, Canada
08

References and documents

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. PubMed 29273485 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01010425
Lead sponsor
Ascendis Pharma A/S
First posted
Nov 10, 2009
Start date
Nov 2009
Primary completion
Feb 2010
Completion
May 2010
Last update
Jun 8, 2010

Study contacts

Ascendis Pharma
study director · Ascendis Pharma A/S

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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