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

Ascendis Pharma A/S44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ACP-001 (TransCon PEG hGH)DRUG

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

ACP-001 (TransCon PEG hGH)DRUG

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

ACP-001 (TransCon PEG hGH)DRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Safety and Tolerability (adverse events, local reactions, immunogenicity)

Time frame: 0-42 days

Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP

Time frame: 0-28 days

Data from ClinicalTrials.gov

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