HealthyPhase 1NCT02124278
Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects
A Phase 1 study testing PUL-042 Inhalation Solution in people with Healthy, run by Pulmotect, Inc. at 1 site in United States.
Trial summary
The purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PUL-042 Inhalation Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females of non-childbearing potential
- Body mass index between 18 and 30 kg/m2
- Normal spirometry
- Normal diffusing capacity of lung for carbon monoxide
- Normal pulse oximetry
- Males willing to practice contraception or have a female partner using contraception
Who cannot join
- Febrile
- Abnormal chest x-ray
- History of tobacco products within the last year and total exposure of > 5 pack/years
- Clinically significant laboratory findings
- History of chronic pulmonary disease
- History of atopic reactions
Show all 16Show fewer
- Mediastinal lymphadenopathy
- Oral corticosteroid therapy within 4 weeks prior to randomization
- Alcohol, caffeine or strenuous exercise within 72 hours prior to dosing
- Grapefruit within 7 days prior to dosing
- Administration of concomitant medications within 14 days prior to dosing
- Exposure to any investigational agent with 30 days
- Significant concurrent illness
- Know positive for HIV, hepatitis B or hepatitis C
- Inability to tolerate a nebulization test with sterile water for injection
- Positive test for drugs of abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Development Solutions
San Antonio, Texas, 77027
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects
The purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects.
Read the detailed description
The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PUL-042 inhalation solutions in healthy subjects.
Subjects will be enter a screening period of up to 14 days to determine eligibility. Subjects will be admitted to the Phase 1 unit the day prior to dosing and remain in the unit until 24 hours post-dose. Subjects will be seen in the clinic at 3 and 7 days post-dose
A modified 3+3 design will be used to determine the maximum tolerated dose (MTD) based on the occurrence of dose-limiting toxicities (DLTs) defined by Common Terminology Criteria for Adverse Events (CTCAE) v4. Additional specific DLTs will be defined as: 1) Hypoxia, defined as a non-artifactual drop in pulse oximetry to < 90% on room air, 2) A decrease in forced expiratory volume in one second (FEV1) of 12% or greater compared to the last observation prior to dosing, 3) Any evidence of bronchospasm or wheezing requiring medical intervention. Doses will be doubled until the maximum tolerated dose (MTD- defined as the largest dose with 0/6 or 1/6 DLTs) is reached.
- Conditions
- Healthy
- Being tested
- PUL-042 Inhalation Solution
- Keywords
- Single ascending dose, Safety and tolerability in healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUL-042 Inhalation SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| PUL-042 Inhalation Solution | Experimental | Fixed dose combination of Pam2CSK4 acetate (Pam2) and ODN M362 (ODN) administered as an inhalation solution. Single dose administration by nebulization. Starting dose will be 2.9 micrograms Pam2: 4.25 micrograms ODN. Up to 7 doubling doses may be tested. Receives: Drug: PUL-042 Inhalation Solution |
| Sterile water for injection | Placebo comparator | Sterile water for injection administered by nebulization Receives: Drug: PUL-042 Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs)
Measured: Dosing to one week post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmotect, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124278
- Sponsor's protocol ID
- PUL-042-001
- Status last verified
- Apr 2015
- First submitted
- 24 Apr 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02124278
- Acronym / sponsor ID
- PUL-042-001
- Conditions
- Healthy
- Keywords
- Single ascending dose, Safety and tolerability in healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pulmotect, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- 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 purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects.
Detailed description
The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PUL-042 inhalation solutions in healthy subjects.
Subjects will be enter a screening period of up to 14 days to determine eligibility. Subjects will be admitted to the Phase 1 unit the day prior to dosing and remain in the unit until 24 hours post-dose. Subjects will be seen in the clinic at 3 and 7 days post-dose
A modified 3+3 design will be used to determine the maximum tolerated dose (MTD) based on the occurrence of dose-limiting toxicities (DLTs) defined by Common Terminology Criteria for Adverse Events (CTCAE) v4. Additional specific DLTs will be defined as: 1) Hypoxia, defined as a non-artifactual drop in pulse oximetry to < 90% on room air, 2) A decrease in forced expiratory volume in one second (FEV1) of 12% or greater compared to the last observation prior to dosing, 3) Any evidence of bronchospasm or wheezing requiring medical intervention. Doses will be doubled until the maximum tolerated dose (MTD- defined as the largest dose with 0/6 or 1/6 DLTs) is reached.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUL-042 Inhalation Solution | Experimental | Drug: PUL-042 Inhalation SolutionFixed dose combination of Pam2CSK4 acetate (Pam2) and ODN M362 (ODN) administered as an inhalation solution. Single dose administration by nebulization. Starting dose will be 2.9 micrograms Pam2: 4.25 micrograms ODN. Up to 7 doubling doses may be tested. |
| Sterile water for injection | Placebo comparator | Drug: PUL-042 Inhalation SolutionSterile water for injection administered by nebulization |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females of non-childbearing potential
- Body mass index between 18 and 30 kg/m2
- Normal spirometry
- Normal diffusing capacity of lung for carbon monoxide
- Normal pulse oximetry
Key exclusion criteria (16 listed)
- Febrile
- Abnormal chest x-ray
- History of tobacco products within the last year and total exposure of > 5 pack/years
- Clinically significant laboratory findings
- History of chronic pulmonary disease
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 |
|---|---|---|
| PUL-042 Inhalation Solution | Drug | PUL-042 Inhalation Solution, Sterile water for injection |
Primary outcome
Dose-limiting toxicities (DLTs)
Time frame: Dosing to one week post-dose
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 29 Apr 2015.
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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 PUL-042 Inhalation Solution in people with Healthy, run by Pulmotect, Inc. at 1 site in United States.
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 6 inclusion and 16 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 29 Apr 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Dose-limiting toxicities (DLTs) (time frame: Dosing to one week post-dose). 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 29 Apr 2015.