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Completed

NCT Number: NCT06659757

A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects

This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

About this study

This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Major 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, 18 to 55 years of age (inclusive) at screening.
  • BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.
  • Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.
  • Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.70.

Major Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI to be clinically relevant.
  • Any respiratory infection or relevant respiratory problem within 14 days of Day 1.

Other inclusion/exclusion eligibility criteria apply.

Treatment and study plan

KIT2014

Drug

KIT2014 will be administered by inhalation with a nebuliser

Placebo

Other

Placebo will be administered by inhalation with a nebuliser

Primary outcomes

  1. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)

    Time frame: Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD

    Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants.

Sponsors and collaborators

Lead sponsor

Kither Biotech Srl

Industry

Collaborators

  • Avance Clinical Pty Ltd.

Registry information

Official study title

A Single-Centre, Double-Blinded, Randomised, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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