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

Phase 1

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Drug: KIT2014; Other: Placebo

• Registration Number: NCT06659757
• Lead Sponsor: Kither Biotech Srl

Brief Summary

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

Detailed Description

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).

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-16
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. 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.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.
4. Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.
5. Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.7.

Major

Exclusion Criteria

1. 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.
2. Any respiratory infection or relevant respiratory problem within 14 days of Day 1.

Other inclusion/exclusion eligibility criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B: Multiple Ascending Dose (MAD)	KIT2014	Healthy volunteers - Up to 3 dose levels of KIT2014 will be evaluated in Part B. Dose levels will be investigated in sequential cohorts (B1 to B3) of 8 healthy participants per cohort (ratio 3:1 active:placebo).
Part A: Single Ascending Dose (SAD)	KIT2014	Healthy volunteers - Up to 6 dose levels of KIT2014 will be evaluated in Part A. Dose levels will be investigated in sequential cohorts (A1 to A6) of 8 healthy participants per cohort (ratio 3:1 active:placebo).
Part A: Single Ascending Dose (SAD)	Placebo	Healthy volunteers - Up to 6 dose levels of KIT2014 will be evaluated in Part A. Dose levels will be investigated in sequential cohorts (A1 to A6) of 8 healthy participants per cohort (ratio 3:1 active:placebo).
Part B: Multiple Ascending Dose (MAD)	Placebo	Healthy volunteers - Up to 3 dose levels of KIT2014 will be evaluated in Part B. Dose levels will be investigated in sequential cohorts (B1 to B3) of 8 healthy participants per cohort (ratio 3:1 active:placebo).

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)	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.

Trial Locations

Locations (1)

CMAX Clinical Research Pty Ltd; 🇦🇺 Adelaide, South Australia, Australia