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

Ascendis Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010425

ACP-001 (Prot. 3695)

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 4 patient groups

ACP-001, dose-level 1

Experimental group

Treatment:

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: Human Growth Hormone

Drug: ACP-001 (TransCon PEG hGH)

Drug: Placebo

ACP-001, dose-level 2

Experimental group

Treatment:

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: Human Growth Hormone

Drug: ACP-001 (TransCon PEG hGH)

Drug: Placebo

ACP-001, dose-level 3

Experimental group

Treatment:

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: Human Growth Hormone

Drug: ACP-001 (TransCon PEG hGH)

Drug: Placebo

ACP-001, dose-level 4

Experimental group

Treatment:

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: ACP-001 (TransCon PEG hGH)

Drug: Human Growth Hormone

Drug: ACP-001 (TransCon PEG hGH)

Drug: Placebo