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The primary objective of this study is to determine the safety and tolerability of AMG 167 following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Six female subjects in each of cohorts 1 to 5 will receive AMG 167; six male subjects in each of cohorts 6 and 8; three female subjects in each of cohorts 7 and 9. |
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| A | Placebo Comparator | Two female subjects in each of cohorts 1 to 5 will receive placebo; two male subjects in each of cohorts 6 and 8; and 1 female subject in each of cohorts 7 and 9. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 167 | Drug | Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV. |
| Measure | Description | Time Frame |
|---|---|---|
| The number (percent) of subjects reporting treatment-emergent adverse events. | Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days | |
| The number of subjects experiencing clinically significant changes in safety laboratory tests, physical examinations, vital signs, or electrocardiograms (ECGs). | Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days | |
| The number of subjects who develop anti-AMG 167 antibodies. | Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic and phamacodynamic parameters [serum procollagen type 1 N-terminal propeptide (P1NP), BSAP, osteocalcin, sCTX, sclerostin levels, and bone mineral density (BMD) for higher dose levels] after single dose SC or IV administration of AMG 167. | Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV. |
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