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

PHASE1RECRUITING

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

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 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 ≥0.7.
  • Exclusion criteria

  • 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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-10-16

    Primary completion: 2025-03-31

    Study completion finish: 2025-04-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT06659757

    Intervention or treatment

    DRUG: KIT2014

    OTHER: Placebo

    Conditions

    • Cystic Fibrosis

    Find a site

    Closest Location:

    CMAX Clinical Research Pty Ltd

    Research sites nearby

    Select from list below to view details:

    • CMAX Clinical Research Pty Ltd

      Adelaide, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Part A: Single Ascending Dose (SAD)
    • 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).
    DRUG: KIT2014
    • KIT2014 will be administered by inhalation with a nebuliser
    EXPERIMENTAL: Part B: Multiple Ascending Dose (MAD)
    • 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
    • KIT2014 will be administered by inhalation with a nebuliser

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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

    Secondary outcome

    Frequently Asked Questions

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    References

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

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