Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACE-083 · 1 trial · 1 indication
Safety/tolerability assessment, following intramuscular administration, includes adverse events, injection site reactions, laboratory measurements, vital signs, etc.
| Arm | Type | Description |
|---|---|---|
| 50 mg single dose | EXPERIMENTAL | 8 subjects in total; 6 subjects to received ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly |
| 100 mg single dose | EXPERIMENTAL | 8 subjects in total; 6 subjects to received ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly |
| 200 mg single dose | EXPERIMENTAL | 8 subjects in total; 6 subjects to received ACE-083 (200 mg) and 2 subjects to receive placebo, single injection, intramuscularly |
| 100 mg multiple dose | EXPERIMENTAL | 8 subjects in total; 6 subjects to received ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly |
| 200 mg multiple dose | EXPERIMENTAL | 8 subjects in total; 6 subjects to received ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly |
| 100 mg (multiple dose) | EXPERIMENTAL | 9 subjects in total; 6 subjects to received ACE-083 (100 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly |
| 150 mg multiple dose | EXPERIMENTAL | 9 subjects in total; 6 subjects to received ACE-083 (150 mg) and 3 subjects to receive placebo, two injections 3 weeks apart, intramuscularly |
| Name | Type | Description |
|---|---|---|
| ACE-083 | DRUG | recombinant fusion protein |
Inclusion Criteria: * Postmenopausal women, defined by follicle stimulating hormone (FSH) level \> 40 IU/L and either 12 months of spontaneous amenorrhea or at least 6 months post-surgical bilateral oophorectomy and/or hysterectomy * BMI 18.5-32 kg/m2 * Clinical laboratory values that meet the foll...
ACE-083 is an investigational small molecule being developed for musculoskeletal diseases. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied for its potential effects on conditions affecting the muscles and skeletal system.
ACE-083 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational drug for musculoskeletal diseases.
ACE-083 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
ACE-083 has one completed Phase 1 clinical trial, identified as NCT02257489. This study, titled "Phase 1 Study of ACE-083 in Healthy Subjects," enrolled 58 female participants aged 45 years and older in the United States. The trial was randomized, double-blind, and controlled.
ACE-083 is a small molecule being studied for musculoskeletal diseases. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not fully characterized in public data.