A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07668518

Enrollment

Registered

2026-06-25

Start date

2026-08-05

Completion date

2027-07-31

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief 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.

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.

Interventions

DRUGKIT2014

KIT2014 will be administered by inhalation with a nebuliser

DRUGPlacebo

Placebo will be administered by inhalation with a nebuliser

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs)	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.

Countries

Australia

Contacts

CONTACTKatrina Asher

katrina@novatrials.com.au+61 2 4058 5477

CONTACTKate Ramage

Kate.Ramage@novatrials.com.au+61 2 4096 1176

PRINCIPAL_INVESTIGATORAlexander Gordon, MBBS FRACP

Novatrials

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026