Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women

PHASE1TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Bone LossOsteoporosis
Interventions
DRUG

CEP-37251

up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) dose of 0.3 mg/kg will be studied.

DRUG

Placebo

up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of Placebo (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) placebo dose of 0.3 mg/kg will be studied.

Trial Locations (1)

5000

Cephalon Investigational Site, Adelaide

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY