NCT07053696

Pharmacokinetics, Safety, and Lung Deposition of 99mTc-DTPA Delivered Via the EDDIS System in Healthy Volunteers

Randomized Phase 1 Study of Safety, Pharmacokinetics, Segmental Lung Deposition, and Digital Validation of a Breath-Actuated EDDIS Inhalation Delivery System Using 99mTc-DTPA in Healthy Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Andrey Petrov · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) - a portable, breath-actuated, digitally monitored system for precision delivery of inhaled agents with automated recording of inspiratory volume, flow, duration, and breath-hold parameters. Drug: 99mTc-DTPA (technetium-99m diethylenetriaminepentaacetic acid) - administered in aqueous solution (0.9% NaCl), radiolabeled for gamma scintigraphic imaging. Total dose: 500-800 µCi in 2 ml solution. Administration: Single-dose inhalation under supervision in a clinical setting.

Detailed description

This Phase 1, single-center, open-label clinical study is designed to evaluate the safety, pharmacokinetics, inhalation dynamics, segmental lung deposition, and digital monitoring capabilities of the breath-actuated EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) when used to deliver a radiolabeled aqueous formulation containing 99mTc-DTPA and a microdose of perfluorocarbon emulsion. The investigational aerosol is administered via a digitally controlled inhalation system that automatically triggers delivery based on the patient's inspiratory effort. The system continuously records real-time parameters including tidal volume, inspiratory flow rate, inhalation duration, and breath-hold time. These data are securely transmitted and stored for analysis, enabling high-resolution correlation between inhalation patterns and lung deposition outcomes. The radiolabel (99mTc-DTPA) is confined to the aqueous phase of the aerosol. The perfluorocarbon emulsion is included to simulate the aerodynamic behavior of complex liquid formulations and to evaluate their interaction with the lung architecture under controlled inhalation conditions. Radiolabeling is not applied to the perfluorocarbon phase, ensuring imaging specificity and avoiding nonspecific signal interference. Imaging will be performed using planar gamma scintigraphy at 0, 15, and 30 minutes post-inhalation. Anterior and posterior projections will be acquired to allow quantitative segmental lung analysis. Measurements will include total deposition, central vs. peripheral distribution, and temporal sedimentation characteristics. In parallel, blood samples will be collected at 1, 2, and 4 hours post-dose to determine systemic pharmacokinetics of the radiolabeled tracer. Urine samples collected at 4 hours will be used to calculate cumulative renal excretion. Adverse events, vital signs, and laboratory parameters will be monitored for 24 hours post-inhalation to assess tolerability and safety. This study aims to establish a validated digital platform for inhaled delivery research and serve as a reference model for future studies involving targeted pulmonary therapeutics and diagnostic aerosols.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Technetium-99m Diethylenetriaminepentaacetic Acid	Technetium-99m Diethylenetriaminepentaacetic Acid A single inhaled dose of 99mTc-DTPA in 0.9% sodium chloride solution, total volume 2 ml, with radioactivity of 500-800 µCi. The solution is radiolabeled only in the aqueous phase to allow gamma scintigraphic imaging of pulmonary deposition. Delivered via breath-actuated EDDIS system. The formulation includes a non-labeled microdose of perfluorocarbon emulsion to simulate clinical aerodynamic behavior.
DEVICE	EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)	Portable, maintenance-free breath-actuated inhalation delivery system with integrated digital sensors. Records real-time data including inspiratory volume, flow rate, duration, and breath-hold time. Provides controlled aerosol delivery and secure transmission of inhalation parameters to the clinical monitoring platform.

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2025-07-08
• Last updated: 2025-11-19

Locations

1 site across 1 country: Switzerland