Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
abaloparatide-sMTS · 2 trials · 2 indications
Maximum observed concentration (Cmax)
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
| Arm | Type | Description |
|---|---|---|
| abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) | EXPERIMENTAL | Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. |
| Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2) | EXPERIMENTAL | Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2). |
| Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min | EXPERIMENTAL | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min | EXPERIMENTAL | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min | EXPERIMENTAL | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min | EXPERIMENTAL | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Name | Type | Description |
|---|---|---|
| abaloparatide-sMTS | COMBINATION_PRODUCT | Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
| abaloparatide-SC | COMBINATION_PRODUCT | Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen |
| abaloparatide-sMTS (Patheon) | COMBINATION_PRODUCT | single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
| abaloparatide-sMTS (Kindeva) | COMBINATION_PRODUCT | single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes |
Inclusion Criteria * Male and female subjects aged 40 to 65 years old, inclusive, at Screening; * Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 32 kg/m\^2; * Laboratory test results within the normal range * S...