Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2NCT07668518
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD
A Phase 1/2 study testing KIT2014 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Kither Biotech Srl at 3 sites in Australia.
Trial summary
Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- KIT2014
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesAustralia
- Study dates
- 5 Aug 2026to 31 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects
- Adult males and females, 40 to 80 years of age (inclusive) at screening.
- Current or former cigarette smokers with a ≥10 pack-year smoking history
- Established physician diagnosis of COPD with associated symptoms defined by the GOLD guidelines for ≥ 12 months of screening.
- FEV1 post-bronchodilator of 40% to 80% of predicted normal at Screening
- Current symptoms of COPD, including bronchitis and/or dyspnoea on moderate exertion at screening.
Who cannot join
- History of life-threatening COPD
- Chronic obstructive pulmonary disease exacerbation requiring oral or parenteral corticosteroids or hospitalisation within 3 months of Screening
- Other clinically active, physician diagnosed moderate to severe respiratory disorders that could interfere with study assessments or confound results (e.g., asthma, bronchiectasis, pulmonary fibrosis, interstitial lung diseases, bronchiolitis obliterans, lung cancer, cor pulmonale, pulmonary hypertension, uncontrolled sleep apnoea, active tuberculosis).
- Other inclusion/exclusion eligibility criteria apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Emeritus Research
Camberwell, Victoria, 3124
Conor Cusack, +61 3 9509 6166, Info@emeritusresearch.com
Jayson Wu, +61 3 9509 6166, Info@emeritusresearch.com
- Recruiting
Novatrials
Charlestown, New South Wales, 2291
Katrina Asher, +61 2 4058 5477, katrina@novatrials.com.au
- Not yet recruiting
Emeritus Research Sydney
Sydney, New South Wales, 2019
Ronald Mak, 0061 2 8964 8186, sydneyinfo@emeritusresearch.com
Parvinca Saini, 0061 2 8964 8186, sydneyinfo@emeritusresearch.com
About this study
Official title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.
Read the detailed description
This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. The study will be conducted in 3 ascending dose cohorts.
- Being tested
- KIT2014, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIT2014Drug
KIT2014 will be administered by inhalation with a nebuliser
PlaceboDrug
Placebo will be administered by inhalation with a nebuliser
| Study group | Role | What they receive |
|---|---|---|
| KIT2014 | Experimental | 24 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels Receives: Drug: KIT2014 |
| Placebo | Experimental | 12 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs)
Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment.
Measured: From first dose to post-treatment follow up visit on Day 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start5 Aug 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kither Biotech Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Alexander Gordon, MBBS FRACP, Principal investigator, Novatrials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668518
- Sponsor's protocol ID
- KIT2014-03
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07668518
- Acronym / sponsor ID
- KIT2014-03
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kither Biotech SrlIndustry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.
Detailed description
This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. The study will be conducted in 3 ascending dose cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIT2014 | Experimental | Drug: KIT201424 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels |
| Placebo | Experimental | Drug: Placebo12 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects
- Adult males and females, 40 to 80 years of age (inclusive) at screening.
- Current or former cigarette smokers with a ≥10 pack-year smoking history
- Established physician diagnosis of COPD with associated symptoms defined by the GOLD guidelines for ≥ 12 months of screening.
- FEV1 post-bronchodilator of 40% to 80% of predicted normal at Screening
Key exclusion criteria (4 listed)
- History of life-threatening COPD
- Chronic obstructive pulmonary disease exacerbation requiring oral or parenteral corticosteroids or hospitalisation within 3 months of Screening
- Other clinically active, physician diagnosed moderate to severe respiratory disorders that could interfere with study assessments or confound results (e.g., asthma, bronchiectasis, pulmonary fibrosis, interstitial lung diseases, bronchiolitis obliterans, lung cancer, cor pulmonale, pulmonary hypertension, uncontrolled sleep apnoea, active tuberculosis).
- Other inclusion/exclusion eligibility criteria apply.
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 |
|---|---|---|
| KIT2014KIT2014 will be administered by inhalation with a nebuliser | Drug | KIT2014 |
| PlaceboPlacebo will be administered by inhalation with a nebuliser | Drug | Placebo |
Primary outcome
Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs)
Time frame: From first dose to post-treatment follow up visit on Day 9.
Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingPhase 2
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
A Study of WIN378 in Participants With Moderate to Severe COPD (Sirius)
COPD (Chronic Obstructive Pulmonary Disease)
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.
Alexander Gordon, MBBS FRACP principal investigator
Novatrials
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KIT2014 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Kither Biotech Srl at 3 sites in Australia.
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 4 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrina Asher (+61 2 4058 5477, katrina@novatrials.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs) (time frame: From first dose to post-treatment follow up visit on Day 9.). 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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.