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A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women

NCT01059435 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-07-05

Study results available
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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.

Conditions

  • Osteopenia

Interventions

DRUG

Romosozumab

Administered subcutaneously or intravenously

DRUG

Placebo

Administered subcutaneously or intravenously

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-13
Primary Completion
2007-07-06
Completion
2007-07-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01059435 on ClinicalTrials.gov