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

Kither Biotech Srl

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: KIT2014

Study type: Interventional

Funder types: Industry

Identifiers

NCT07668518

KIT2014-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 2 patient groups

KIT2014

Experimental group

Description:

24 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels

Treatment:

Drug: KIT2014

Placebo

Experimental group

Description:

12 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels

Treatment:

Drug: Placebo