Healthy VolunteersPhase 1NCT05999942
A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants
A Phase 1 study testing Liposomal Amikacin for Inhalation in people with Healthy Volunteers, run by Insmed Incorporated.
Trial summary
The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Liposomal Amikacin for Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2004to 29 Jun 2004
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with a body mass index (BMI) of 20-28.
- Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.
- Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
Who cannot join
- Participants who had clinically diagnosed asthma.
- Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. [^99m]Tc, or [^111]In, and [^81m]Kr).
- Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction.
- History of smoking within the past 12 months.
- History of chronic cough or wheezing within the previous 21 days.
- Participants who had an upper respiratory illness or infection within the previous 21 days.
Show all 9Show fewer
- A history of drug or alcohol abuse.
- Donation of 450 milliliters (mL) or more blood within the previous 12 weeks.
- Note: Other inclusion/exclusion criteria may apply.
About this study
Official title: A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers
The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.
- Conditions
- Healthy Volunteers
- Being tested
- Liposomal Amikacin for Inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Amikacin for InhalationDrug
Also called Amikacin Liposome Inhalation Suspension (ALIS),, Arikayce™
Administered via the Pari LC STAR™ nebulizer.
| Study group | Role | What they receive |
|---|---|---|
| Amikacin Liposome Inhalation | Experimental | Participants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1. Receives: Drug: Liposomal Amikacin for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs
Measured: Pre-administration and 2 hours post-administration on Day 1
Secondary outcomes (4)
Percent Dose Deposited in Oropharyngeal and Stomach Region
Measured: At multiple timepoints post-administration up to Day 2
Percent Dose Remaining in the Device Including the Mouthpiece
Measured: At multiple timepoints post-administration up to Day 2
Percent Dose Remaining in the Low Resistance Exhalation Filter
Measured: At multiple timepoints post-administration up to Day 2
Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P)
Measured: Pre-administration and 2 hours post- administration on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start2 Jun 2004
- Primary completion29 Jun 2004
- Study completion29 Jun 2004
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999942
- Sponsor's protocol ID
- RD 201/23924
- Status last verified
- Jul 2023
- First submitted
- 11 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gamma Scintigraphy Study to Investigate the Lung Deposition of Inhaled Amikacin-Loaded Liposomes in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05999942
- Acronym / sponsor ID
- RD 201/23924
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2004 (actual)
- Primary completion
- 29 Jun 2004 (actual)
- Study completion
- 29 Jun 2004 (actual)
- First posted
- 21 Aug 2023 (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.
The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amikacin Liposome Inhalation | Experimental | Drug: Liposomal Amikacin for InhalationParticipants will receive a single dose of radiolabelled amikacin loaded liposomes by inhalation on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with a body mass index (BMI) of 20-28.
- Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.
- Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.
Key exclusion criteria (9 listed)
- Participants who had clinically diagnosed asthma.
- Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. [^99m]Tc, or [^111]In, and [^81m]Kr).
- Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction.
- History of smoking within the past 12 months.
- History of chronic cough or wheezing within the previous 21 days.
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 |
|---|---|---|
| Liposomal Amikacin for InhalationAlso: Amikacin Liposome Inhalation Suspension (ALIS),, Arikayce™Administered via the Pari LC STAR™ nebulizer. | Drug | Amikacin Liposome Inhalation |
Primary outcome
Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs
Time frame: Pre-administration and 2 hours post-administration on Day 1
4 secondary outcomes
Percent Dose Deposited in Oropharyngeal and Stomach Region
Time frame: At multiple timepoints post-administration up to Day 2
Percent Dose Remaining in the Device Including the Mouthpiece
Time frame: At multiple timepoints post-administration up to Day 2
Percent Dose Remaining in the Low Resistance Exhalation Filter
Time frame: At multiple timepoints post-administration up to Day 2
Penetration Index Based on the Ratio of Counts in the Central:Peripheral Lung Regions, Corrected for Regional Lung Volume (sC/P)
Time frame: Pre-administration and 2 hours post- administration on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal Amikacin for Inhalation in people with Healthy Volunteers, run by Insmed Incorporated.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulmonary Deposition of Radiolabelled Amikacin-loaded Liposomes Measured as Percentage Retention of Emitted Dose Deposited in the Lungs (time frame: Pre-administration and 2 hours post-administration on Day 1). 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 21 Aug 2023.