A First-in-human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women

PHASE1CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Osteopenia
Interventions
DRUG

AMG 167

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.

DRUG

Placebo

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY