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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

April 10, 2026

Study Completion Date

September 21, 2026

Conditions
Healthy Volunteers
Interventions
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.

Trial Locations (1)

CH-1005

Andrey Petrov Dr, Lausanne

All Listed Sponsors
collaborator

Ruslan Lytvin

UNKNOWN

lead

Andrey Petrov

OTHER