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Trial · Interventional

CompletedPhase 1Registry data

A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

Overview

Status
Completed
Phase
Phase 1
Enrollment
48 participants (actual)
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA · Industry
Design
Randomized · Double masking
Countries
1 country

Canada

Start
Sept 2008
Primary completion
Jul 2009
Completion
Jul 2009
First posted
19 Sept 2008 (estimated)
Last update posted
14 Jul 2009 (estimated)
Conditions
Muscle Loss

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 1

    A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

    NCT00755638

    Sept 2008 to Jul 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers

Interventions

  • ACE-031Biological

Arms1

  • Experimental

    single

    8 subjects (6 active and 2 placebo)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers

    Time frame · specified timepoints in the protocol

Secondary outcomes(1)
  1. To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031

    Time frame · specified timepoints in the protocol

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: 1. Subject is a postmenopausal woman, 45-75 years old (inclusive) 2. Subject has a body mass index (BMI) of \> 18.5 to \< 30 3. Subject must give written informed consent Key Exclusion Criteria: 1. Subject has a history of malignancy. However, a subject with a history of excised or treated basal cell carcinoma, cervical carcinoma in-situ, or less than or equal to 2 squamous cell carcinomas is eligible to participate in this study. 2. Subject has a history of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. 3. Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry. 4. Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia). 5. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening. 6. Subject has a history of severe allergic or anaphylactic reactions. 7. Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures). 8. Subject had a fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing. 9. Subject has a positive Tuberculin skin test (Mantoux) 10. Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV). 11. Subject has a recent or clinically significant history of drug or alcohol abuse, or tests positive in a urine screen for alcohol or drugs of abuse. 12. Subject consumed any alcohol within 48 hours prior to dosing. 13. Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration. 14. Subject has taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study.

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