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New treatment option for Cystic Fibrosis
Official title A Study Assessing KB407 for the Treatment of Cystic Fibrosis
ClinicalTrials.gov ID: NCT05504837
What this study is testing
What is KB407 (Nebulization)?
KB407 (Nebulization) is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for cystic fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must...
- people aged 18 years or older at the time of Informed Consent
- 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
You likely can't join if
- Initiation of any new chronic therapy (eg, CFTR modulator, hypertonic saline, inhaled antibiotic) or any change in chronic therapy (excluding...
- Hospitalization, sinopulmonary infection, CF exacerbation, or other clinically significant infection or illness 14 days prior to the first dose that...
- Treatment for Mycobacterium abscessus within 3 months prior to the first dose or more than two pulmonary exacerbations with a history of Burkholderia...
- Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to the first...
- History of or listed for solid organ transplantation
- Any condition (including a history or current evidence of substance abuse or dependence, uncontrolled asthma, or is considered to be...
See the full eligibility criteria
- 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
- people aged 18 years or older at the time of Informed Consent
- 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
- Clinically stable in the opinion of the Investigator
- Percent predicted FEV1 ≥40% and ≤90% of the predicted normal for age, gender, and height at Screening
- Resting oxygen saturation ≥92% on room air at Screening
- 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
- 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
- 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
- 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
- History of or listed for solid organ transplantation
- 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...
- An active oral herpes infection 30 days prior to the first dose
- Women who are pregnant or nursing
- Subject who is unwilling to comply with contraception requirements per protocol
- Clinically significant abnormalities of hematology or chemistry testing at Screening that the Investigator believes may interfere with the assessment of safety and/or how well it works of the study treatment
- Subject has a known hypersensitivity to inhaled glycerol
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator
- Bronchoscopy participants only: Unable to tolerate bronchoscopy procedure and airway sampling, in the opinion of the Investigator
- Cohort 4 participants only: people who are ineligible for, do not tolerate, or do not benefit from modulator therapy
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Boise, Idaho, United States
- Northfield, Illinois, United States
- Hawthorne, New York, United States
- New York, New York, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Boise, Idaho, United States; Northfield, Illinois, United States; Hawthorne, New York, United States; New York, New York, United States; Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.