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

NCT07668518 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: KIT2014-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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.

  From first dose to post-treatment follow up visit on Day 9.

Study Arms (2)

KIT2014

EXPERIMENTAL

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

Drug: KIT2014

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

KIT2014 DRUG

KIT2014 will be administered by inhalation with a nebuliser

KIT2014

Placebo DRUG

Placebo will be administered by inhalation with a nebuliser

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kither Biotech Srl: lead
• Avance Clinical Pty Ltd.: collaborator

Study Sites (1)

Novatrials

Charlestown, New South Wales, 2291, Australia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Gordon, MBBS FRACP

  Novatrials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Asher

CONTACT

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

Kate Ramage

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)