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

NCT00755638 | Completed Phase 1

• 1 other identifier: A031-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (1)

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

  specified timepoints in the protocol

Secondary Outcomes (1)

• To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031

  specified timepoints in the protocol

Study Arms (1)

single

EXPERIMENTAL

8 subjects (6 active and 2 placebo)

Biological: ACE-031

Interventions

ACE-031 BIOLOGICAL

single subcutaneous dose of ACE-031

single

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a postmenopausal woman, 45-75 years old (inclusive)
• Subject has a body mass index (BMI) of \> 18.5 to \< 30
• Subject must give written informed consent

You may not qualify if:

• 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.
• 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.
• 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.
• Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia).
• Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
• Subject has a history of severe allergic or anaphylactic reactions.
• Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures).
• Subject had a fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing.
• Subject has a positive Tuberculin skin test (Mantoux)
• Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV).
• 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.
• Subject consumed any alcohol within 48 hours prior to dosing.
• Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration.
• 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.

Sponsors & Collaborators

• Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: lead

Study Sites (1)

Acceleron Investigative Site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

ACVR2B protein, human

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 19, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

CA (1)