CompletedPhase 1

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

Australia56 participantsStarted 2024-10-16

Plain-language summary

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

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

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

NCT IDNCT06659757

SponsorKither Biotech Srl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-14