Healthy VolunteersPhase 1EDDIS-PKNCT07053696
Pharmacokinetics, Safety, and Lung Deposition of 99mTc-DTPA Delivered Via the EDDIS System in Healthy Volunteers
A Phase 1 study testing Technetium-99m Diethylenetriaminepentaacetic Acid and EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) in people with Healthy Volunteers, run by Andrey Petrov at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Technetium-99m Diethylenetriaminepentaacetic Acid and EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Mar 2025to 17 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 45 years
- Healthy adults with no clinically significant medical history
- Normal spirometry (FEV1 ≥ 80% predicted)
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
- No prior exposure to radiopharmaceuticals in the past 12 months
- Able and willing to comply with study procedures and provide written informed consent
- Current or past use of tobacco products or electronic nicotine delivery systems (e.g., e-cigarettes) is not an exclusion criterion
Who cannot join
- History of asthma, COPD, or other chronic respiratory conditions
- History of lung surgery, pulmonary embolism, or interstitial lung disease
- Any ongoing respiratory infection or fever ≥ 38.0°C at screening or study day
- Uncontrolled or progressive arterial hypertension
- Known cardiovascular disease (e.g., arrhythmia, ischemic heart disease, heart failure)
- Presence of blood in saliva, hemoptysis, or any known pulmonary bleeding
Show all 14Show fewer
- Diagnosed pulmonary emphysema
- Known coagulation disorders or use of anticoagulant therapy
- History of hypersensitivity to perfluorocarbons, DTPA, or radiopharmaceutical agents
- Prior exposure to radiopharmaceuticals within the last 12 months
- Participation in another clinical trial within the last 60 days
- Pregnancy or breastfeeding
- Use of any investigational or prescription drug within 30 days prior to study drug administration
- Any condition which, in the opinion of the investigator, would pose a health risk or interfere with study interpretation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Technetium-99m Diethylenetriaminepentaacetic Acid, EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)
- Keywords
- Inhalation Device, Lung Deposition, Aerosol, Pulmonary Drug Delivery, Radiolabeled Aerosol, Technetium Tc 99m DTPA, Scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium-99m Diethylenetriaminepentaacetic AcidDrug
Also called 99mTc-DTPA
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.
EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)Device
Also called EDDIS digital inhaler, breath-actuated inhalation device
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Inhalation of 99mTc-DTPA via EDDIS System | Experimental | This arm includes all participants receiving a single inhaled dose of 99mTc-DTPA (radiolabeled aqueous solution in 0.9% NaCl, 2 ml total volume, 500-800 µCi), administered via the portable, breath-actuated EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System).
The procedure includes real-time digital recording of inspiratory parameters and post-inhalation planar scintigraphic imaging at 0, 15, and 30 minutes to assess pulmonary deposition.
Pharmacokinetic samples (blood and urine) are collected for systemic exposure analysis. No control or comparator arm is included. Receives: Drug: Technetium-99m Diethylenetriaminepentaacetic Acid; Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental lung deposition of 99mTc-DTPA measured by planar gamma scintigraphy
Quantitative analysis of 99mTc-DTPA distribution in lung segments using planar gamma scintigraphy imaging system with anterior/posterior views at 0, 15, and 30 minutes post-dose. Results expressed as percentage of total deposited dose per lung segment.
Measured: Within 30 minutes post-inhalation
Incidence of treatment-emergent adverse events (TEAEs) assessed by clinical evaluation
Number and severity of adverse events recorded after a single inhalation of 99mTc-DTPA via the EDDIS system, assessed through standardized clinical observation checklist, vital signs monitoring (blood pressure, heart rate, respiratory rate, temperature), and structured subject symptom reports using Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Within 24 hours post-inhalation
Secondary outcomes (3)
Radioactivity concentration in venous blood samples measured using gamma counter to determine systemic absorption of inhaled 99mTc-DTPA over time. Results expressed as counts per minute per milliliter (cpm/mL)
Radioactivity in venous blood samples to determine systemic absorption of inhaled 99mTc-DTPA over time
Measured: Up to 4 hours post-dose (samples at 1, 2, and 4 hours)
Cumulative urinary excretion of 99mTc-DTPA measured by gamma counter analysis
Total radioactivity in collected urine samples measured using gamma counter to estimate renal elimination of 99mTc-DTPA. Results expressed as percentage of administered dose excreted
Measured: up to 4 hours post-dose
Digital accuracy of inspiratory parameter recording assessed by calibration comparison
Comparison of EDDIS-recorded inspiratory volume (mL), flow rate (L/min), inhalation time (seconds), and breath-hold duration (seconds) with reference calibration measurements using validated spirometry equipment. Accuracy expressed as percentage deviation from reference values.
Measured: During inhalation procedure (real-time measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start17 Mar 2025
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Why it stopped: Changing regulatory requirements requiring changes in study design. Participants were not enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive a single inhaled dose of radiolabeled aerosol (99mTc-DTPA) via the EDDIS system under controlled conditions.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrey Petrov
- Sponsor type
- University, hospital or other
- Collaborators
- Ruslan Lytvin
- Responsible party
- Sponsor-investigator, Andrey Petrov, Petrov, Andrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053696
- Sponsor's protocol ID
- EDDIS-PK-01
- Acronym
- EDDIS-PK
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a non-therapeutic, device validation study with radiolabeled imaging in healthy volunteers. No individual-level participant data will be shared. Aggregated, de-identified study results may be published in scientific journals or presented at scientific meetings.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07053696
- Acronym / sponsor ID
- EDDIS-PK / EDDIS-PK-01
- Conditions
- Healthy Volunteers
- Keywords
- Inhalation Device, Lung Deposition, Aerosol, Pulmonary Drug Delivery, Radiolabeled Aerosol, Technetium Tc 99m DTPA, Scintigraphy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changing regulatory requirements requiring changes in study design. Participants were not enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrey PetrovUniversity, hospital or other
- Collaborators
- Ruslan Lytvin
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive a single inhaled dose of radiolabeled aerosol (99mTc-DTPA) via the EDDIS system under controlled conditions.
| Arm | Type | Receives |
|---|---|---|
| Single Inhalation of 99mTc-DTPA via EDDIS System | Experimental | Drug: Technetium-99m Diethylenetriaminepentaacetic Acid, Device: EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)This arm includes all participants receiving a single inhaled dose of 99mTc-DTPA (radiolabeled aqueous solution in 0.9% NaCl, 2 ml total volume, 500-800 µCi), administered via the portable, breath-actuated EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System). The procedure includes real-time digital recording of inspiratory parameters and post-inhalation planar scintigraphic imaging at 0, 15, and 30 minutes to assess pulmonary deposition. Pharmacokinetic samples (blood and urine) are collected for systemic exposure analysis. No control or comparator arm is included. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 45 years
- Healthy adults with no clinically significant medical history
- Normal spirometry (FEV1 ≥ 80% predicted)
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
- No prior exposure to radiopharmaceuticals in the past 12 months
Key exclusion criteria (14 listed)
- History of asthma, COPD, or other chronic respiratory conditions
- History of lung surgery, pulmonary embolism, or interstitial lung disease
- Any ongoing respiratory infection or fever ≥ 38.0°C at screening or study day
- Uncontrolled or progressive arterial hypertension
- Known cardiovascular disease (e.g., arrhythmia, ischemic heart disease, heart failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technetium-99m Diethylenetriaminepentaacetic AcidAlso: 99mTc-DTPATechnetium-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. | Drug | Single Inhalation of 99mTc-DTPA via EDDIS System |
| EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System)Also: EDDIS digital inhaler, breath-actuated inhalation devicePortable, 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. | Device | Single Inhalation of 99mTc-DTPA via EDDIS System |
Primary outcome
Segmental lung deposition of 99mTc-DTPA measured by planar gamma scintigraphy
Time frame: Within 30 minutes post-inhalation
Quantitative analysis of 99mTc-DTPA distribution in lung segments using planar gamma scintigraphy imaging system with anterior/posterior views at 0, 15, and 30 minutes post-dose. Results expressed as percentage of total deposited dose per lung segment.
Incidence of treatment-emergent adverse events (TEAEs) assessed by clinical evaluation
Time frame: Within 24 hours post-inhalation
Number and severity of adverse events recorded after a single inhalation of 99mTc-DTPA via the EDDIS system, assessed through standardized clinical observation checklist, vital signs monitoring (blood pressure, heart rate, respiratory rate, temperature), and structured subject symptom reports using Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
3 secondary outcomes
Radioactivity concentration in venous blood samples measured using gamma counter to determine systemic absorption of inhaled 99mTc-DTPA over time. Results expressed as counts per minute per milliliter (cpm/mL)
Time frame: Up to 4 hours post-dose (samples at 1, 2, and 4 hours)
Cumulative urinary excretion of 99mTc-DTPA measured by gamma counter analysis
Time frame: up to 4 hours post-dose
Digital accuracy of inspiratory parameter recording assessed by calibration comparison
Time frame: During inhalation procedure (real-time measurement)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. This is a non-therapeutic, device validation study with radiolabeled imaging in healthy volunteers. No individual-level participant data will be shared. Aggregated, de-identified study results may be published in scientific journals or presented at scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Technetium-99m Diethylenetriaminepentaacetic Acid and EDDIS-IDDS (Enhanced Digital Dose Inhalation Delivery System) in people with Healthy Volunteers, run by Andrey Petrov at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental lung deposition of 99mTc-DTPA measured by planar gamma scintigraphy (time frame: Within 30 minutes post-inhalation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.