NCT06659757

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Kither Biotech Srl · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	KIT2014	KIT2014 will be administered by inhalation with a nebuliser
OTHER	Placebo	Placebo will be administered by inhalation with a nebuliser

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2024-10-26
• Last updated: 2025-08-05

Locations

1 site across 1 country: Australia