Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)
Dose-ascending, Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH)
1 other identifier
interventional
44
1 country
1
Brief Summary
Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2009
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJune 8, 2010
June 1, 2010
3 months
November 6, 2009
June 7, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and Tolerability (adverse events, local reactions, immunogenicity)
0-42 days
Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP
0-28 days
Study Arms (4)
ACP-001, dose-level 1
EXPERIMENTALACP-001, dose-level 2
EXPERIMENTALACP-001, dose-level 3
EXPERIMENTALACP-001, dose-level 4
EXPERIMENTALInterventions
Placebo, s.c., single-dose
Human Growth Hormone, s.c., daily for 7 days
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- to 45 years old
- Body Mass Index of 18.5 kg/m2 and less than or equal to 29.9 kg/m2
- Others
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 29273485DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ascendis Pharma
Ascendis Pharma A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 10, 2009
Study Start
November 1, 2009
Primary Completion
February 1, 2010
Study Completion
May 1, 2010
Last Updated
June 8, 2010
Record last verified: 2010-06