Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02257489 | Phase 1 Study of ACE-083 in Healthy Subjects | PHASE1 | COMPLETED | 58 | — | — | Sep 1, 2014 | Apr 1, 2016 | Sep 23, 2022 | 1 | United States |
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...