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

ClinicalTrials.gov ID

NCT07668518

Lead Sponsor

Kither Biotech SrlINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

36Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Aug 5, 2026Actual

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Jul 31, 2027Estimated

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

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.

• Chronic Obstructive Pulmonary Disease (COPD)

• KIT2014
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

Double

Lead Sponsor

Kither Biotech SrlINDUSTRY

Collaborators

Avance Clinical Pty Ltd.INDUSTRY

Info@emeritusresearch.com+61 3 9509 6166

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