NCT07312643

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

A Phase 1, Open-label, Randomized, Crossover 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This single-center Phase 1 study in healthy male and female subjects of 18 to 55 years (inclusive) will follow an open-label, randomized, single-dose, crossover design with 2 intervention periods. The purpose of this study is to assess and compare the pharmacokinetic characteristics and the safety of single doses of pasireotide when administered subcutaneously by reusable ServoPen with cartridge or by syringe drawn from an ampule in healthy subjects.

Detailed description

Study details include: * The study duration will be approximately 6.5 weeks per subject. * Two (2) intervention periods are planned per dose level (50 µg and 200 µg), with 1 of the following interventions administered per period: * Single dose of 50 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge. * Single dose of 200 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge. * Single dose of 50 µg pasireotide administered subcutaneously using syringe drawn from an ampule. * Single dose of 200 µg pasireotide administered subcutaneously using syringe drawn from an ampule. * The screening examination will be performed within 28 to 2 days prior to the first administration of study intervention. * Subjects will stay in-house for at least 3 days per period. * The ambulatory follow-up visit will be performed within 7 to 10 days after the last administration of study intervention.

Conditions

• Pharmacokinetics
• Safety

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Pasireotide cartridge with reusable ServoPen	Pasireotide cartridge with reusable ServoPen
DRUG	Pasireotide ampule with syringe	Pasireotide ampule with syringe

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-02-03
• Completion: 2026-02-03
• First posted: 2025-12-31
• Last updated: 2026-02-04

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study