Clinical trial NCT00755638: A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy, Postmenopausal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscle Loss
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers
timeFrame: specified timepoints in the protocol
Secondary outcomes:
measure: To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031
timeFrame: specified timepoints in the protocol
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Acceleron Investigative Site
state: Quebec
Study officials:
References: