A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: ACP-001 (TransCon hGH); ACP-001 (TransCon hGH); ACP-001 (TransCon hGH); Omnitrope
Intervention description: s.c., weekly injection; s.c., weekly injection; s.c., weekly injection; s.c., daily injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study investigates the safety, tolerability, pharmacokinetic profile (PK), and
      pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared
      to one dose-level of an approved daily human growth hormone product over a period of 4 weeks
      (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone
      Deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 20 to 70 years

          -  Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive

          -  Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone
             deficiency as defined in the Consensus guidelines for the diagnosis and treatment of
             adults with GH deficiency II (Consensus Guidelines 1998 and 2007)

          -  Fertile females must agree to use appropriate contraceptive methods and have a
             negative pregnancy test at inclusion

          -  GH replacement therapy for at least 3 months

          -  Willing to maintain current activity level during the trial

          -  Subjects are able and willing to provide written informed consent and authorization
             for protected health information disclosure in accordance with Good Clinical Practice
             (GCP)

        Exclusion Criteria:

          -  History of hypersensitivity and/or idiosyncrasy to any of the test compounds or
             excipients employed in this study.

          -  Females of childbearing potential who are pregnant, breast-feeding or intend to become
             pregnant or are not using adequate contraceptive methods. Reliable methods for women
             are orally administered hormonal contraceptives, surgical intervention (e.g. tubal
             ligation), intrauterine device (IUD) and sexual abstinence.

          -  Active malignant disease or malignant disease within the last 5 years

          -  Proliferative retinopathy judged by retina-photo within the last year

          -  Heart insufficiency as judged by the investigator and/or NYHA 3 or greater (NYHA
             criteria for diagnosis of diseases of the heart, 1994)

          -  Subjects with uncontrolled diabetes with an HbA1c above 8.0% and/or insulin treatment

          -  Stable pituitary hormone replacement therapy for less than 3 months

          -  Impaired liver function as judged by the investigator or hepatic transaminases > 2
             times the upper limit of normal

          -  Impaired kidney function as judged by the investigator and/or creatinine clearance <50
             mL/min and/or serum creatinine > 1.4 mg/dL

          -  Participation in another interventional clinical study involving an investigational
             compound within 3 months prior to enrolment in this study or participation in another
             interventional clinical study involving an investigational compound during this study.

          -  Subjects who are unable to comply with the requirements of the study or who in the
             opinion of the investigator should not participate in the study.

          -  History or presence of alcohol abuse or drug abuse.

          -  Patients with known history for, or presence of, anti-hGH and / or anti-PEG antibodies