Conditions: Osteopenia
Keywords: Amgen First in Human Postmenopausal Phase 1
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 74
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.

Detailed description:

Arms:
arm 1: Participants were randomized to receive a single dose of matching placebo administered by subcutaneous or intravenous injection. arm 2: Participants were randomized to receive a single dose of romosozumab administered by subcutaneous or intravenous injection. The starting dose was 0.1 mg/kg, with sequential escalation up to 10 mg/kg.

Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously or intravenously intervention 2: Administered subcutaneously or intravenously

Protocol document: