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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010425

Enrollment

Registered

2009-11-10

Start date

2009-11-30

Completion date

2010-05-31

Last updated

2010-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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).

Interventions

DRUGACP-001 (TransCon PEG hGH)

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

DRUGPlacebo

Placebo, s.c., single-dose

DRUGHuman Growth Hormone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026