Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

What Was Tested

In this phase 1 trial, researchers set out to test Abaloparatide.

It had two arms (groups): abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2) (experimental) and Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (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) application followed by Abaloparatide-SC injection (Period 2).

The registry classes the interventions as combination product.

Who Took Part

The registry lists 52 actual participants took part.

It was open to people of any sex aged from 40 years up to 65 years.

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

Examples of who could join: Male and female subjects aged 40 to 65 years old, inclusive, at Screening;. Laboratory test results 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

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the Abaloparatide group and the comparison group should start out alike.

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 2021-03-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PK Cmax. PK AUC1. PK AUC2.

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

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Abaloparatide in 52 people.

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.