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

NCT06659757 | Completed Phase 1

• 1 other identifier: KIT2014-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

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) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants.

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

Study Arms (2)

Part A: Single Ascending Dose (SAD)

EXPERIMENTAL

Healthy volunteers - Up to 4 dose levels of KIT2014 will be evaluated in Part A. Dose levels will be investigated in sequential cohorts (A1 to A4) of 8 healthy participants per cohort (ratio 3:1 active:placebo).

Drug: KIT2014; Other: Placebo

Part B: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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).

Drug: KIT2014; Other: Placebo

Interventions

KIT2014 DRUG

KIT2014 will be administered by inhalation with a nebuliser

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD)

Placebo OTHER

Placebo will be administered by inhalation with a nebuliser

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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, 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

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: October 22, 2024
• First Posted: October 26, 2024
• Study Start: October 16, 2024
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)