Conditions: Adult Growth Hormone Deficiency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks arm 2: Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks arm 3: Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks arm 4: Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks

Interventions: intervention 1: ACP-001 (TransCon hGH) intervention 2: ACP-001 (TransCon hGH) intervention 3: ACP-001 (TransCon hGH) intervention 4: Omnitrope
Intervention descriptions: intervention 1: s.c., weekly injection intervention 2: s.c., weekly injection intervention 3: s.c., weekly injection intervention 4: s.c., daily injection

Protocol document: