Recent Updates
Recently added Catalysts

ACE-031

Phase 1

Muscle Loss | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Jul 14, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00755638A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal VolunteersPHASE1 COMPLETED 48Sep 1, 2008Jul 1, 2009Jul 14, 20091 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of single, escalating doses of ACE-031 in healthy postmenopausal volunteers
specified timepoints in the protocol
Secondary Endpoints
To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of ACE-031
specified timepoints in the protocol
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
singleEXPERIMENTAL8 subjects (6 active and 2 placebo)
Interventions
NameTypeDescription
ACE-031BIOLOGICALsingle subcutaneous dose of ACE-031
Unlock Study Design Details
Eligibility Criteria
Age Range45 Years — 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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 e...

Countries:Canada
Unlock Eligibility Criteria
Competitive Landscape -Muscle Disorders 4 trials
Unlock Competitive Intelligence