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

Kither Biotech Srl

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Other: Placebo; Drug: KIT2014

Study type: Interventional

Funder types: Industry

Identifiers

NCT06659757

KIT2014-01

Details and patient eligibility

About

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

Full 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).

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Major 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 ≥0.70.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

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).

Treatment:

Drug: KIT2014

Other: Placebo

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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).

Treatment:

Drug: KIT2014

Other: Placebo