Conditions: Osteopenia
Keywords: Amgen Phase 1 Postmenopausal Japanese
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 31
Healthy volunteers: yes

Brief summary:
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.

Detailed description:

Arms:
arm 1: Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab. arm 2: Participants will receive a single dose of placebo.

Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol document: