Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule

What Was Tested

This registered phase 1 trial tested Pasireotide.

It had four arms (groups): one (experimental), one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as combination product and drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: A subject is eligible only if all of the following criteria apply:. Age of 18 to 55 years inclusive, at the time of signing the informed consent. BMI ≥18.5 kg/m2. Male or female. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and ECG.

The full record lists 46 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and open-label.

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

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

Everyone knew when Pasireotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-12-01 with completion listed for 2026-02-03.

It ran at 1 site in Germany.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: AUC0-tlast (time frame: 2 weeks). AUC0-inf (time frame: 2 weeks). Cmax (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pasireotide in 40 people.

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

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