KB407-02

Evaluating Safety and Tolerability of Nebulized Investigational Medication in Adults with Cystic Fibrosis

Recruiting
18 years or above
All
Phase 1
20 participants needed
1 Location

Brief description of study

This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  1. The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions
  2. Subjects aged 18 years or older at the time of Informed Consent
  3. A confirmed diagnosis of CF as defined by clinical signs and symptoms of CF and at least one of the following:
    • A historical sweat chloride value >60 mmol/L
    • Two copies of a disease causing mutation in the CFTR gene
  4. Clinically stable in the opinion of the Investigator
  5. Percent predicted FEV1 ≥40% and ≤90% of the predicted normal for age, gender, and height at Screening
  6. Resting oxygen saturation ≥92% on room air at Screening

Exclusion Criteria:

  1. Initiation of any new chronic therapy (eg, CFTR modulator, hypertonic saline, inhaled antibiotic) or any change in chronic therapy (excluding pancreatic enzyme replacement therapy) within 28 days prior to the first dose
  2. Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness 14 days prior to the first dose that, in the opinion of the Investigator, may confound study results
  3. Treatment for Mycobacterium abscessus within 3 months prior to the first dose or more than two pulmonary exacerbations with a history of Burkholderia cenocepacia infection within 6 months prior to the first dose
  4. Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to the first dose
  5. History of or listed for solid organ transplantation
  6. Any condition (including a history or current evidence of substance abuse or dependence, uncontrolled asthma, or is considered to be immunocompromised) that, in the opinion of the Investigator, would impact a subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB407
  7. An active oral herpes infection 30 days prior to the first dose
  8. Women who are pregnant or nursing
  9. Subject who is unwilling to comply with contraception requirements per protocol
  10. Clinically significant abnormalities of hematology or chemistry testing at Screening that the Investigator believes may interfere with the assessment of safety and/or efficacy of the study treatment
  11. Subject has a known hypersensitivity to inhaled glycerol
  12. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator
  13. Bronchoscopy participants only: Unable to tolerate bronchoscopy procedure and airway sampling, in the opinion of the Investigator
  14. Cohort 4 participants only: Subjects who are ineligible for, do not tolerate, or do not benefit from modulator therapy

This study investigates the safety and tolerability of an investigational medication in adults with cystic fibrosis.

The purpose of this study is to evaluate how well people tolerate different doses of the investigational medication when it is inhaled as a mist. The study will look at how the body responds to the medication and check for any side effects.

  • Who can participate: Adults aged 18 years or older with a confirmed diagnosis of cystic fibrosis can participate.
  • Study details: Participants will inhale the investigational medication through a nebulizer. A placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine, may be used.
Updated on 07 May 2026. Study ID: 25-1231

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