Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

What Was Tested

The trial (phase 1) is built around Abaloparatide.

It had four arms (groups): Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min (experimental), Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min (experimental), Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min (experimental) and 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).

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).

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).

The registry classes the interventions as combination product.

More on the Plan

The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.

Who Took Part

The registry lists 36 actual participants took part.

It was open to women only aged from 40 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Female subjects aged 40 to 65 years old, inclusive, at Screening. Laboratory tests within the normal range. Serum 25-hydroxyvitamin D values must be \> 20 ng/mL.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: history of any cancer within the past 5 years other than squamous or basal cell carcinoma;.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Abaloparatide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Abaloparatide and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Abaloparatide study: the participants and staff both knew the treatment.

It started in 2020-11-16 with completion listed for 2021-02-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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-∞).

It also tracked 1 secondary outcome, for example Subjects with treatment-emergent AEs and SAEs.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Abaloparatide in 36 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Abaloparatide compound page, all human trials.