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Virus Therapy
Nebulized KB407 for Cystic Fibrosis
Phase 1
Recruiting
Research Sponsored by Krystal Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Two copies of a disease causing mutation in the CFTR gene
Subjects aged 18 years or older at the time of Informed Consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Study Summary
This trial will study whether it is safe to give increasing doses of nebulized KB407 to adults with cystic fibrosis.
Who is the study for?
Adults with cystic fibrosis who understand and agree to the study's procedures can join. They must have a confirmed diagnosis, stable health, specific lung function levels, normal oxygen saturation without assistance, and two CFTR gene mutations. Excluded are those recently ill or hospitalized, vaccinated close to treatment start, on certain antibiotics recently or with conditions that could affect safety assessments.Check my eligibility
What is being tested?
The trial is testing KB407 through nebulization to see how safe it is and how well people tolerate different doses. It's for adults with cystic fibrosis. Participants will receive ascending doses of KB407 via a nebulizer which turns liquid medication into a mist.See study design
What are the potential side effects?
Specific side effects of KB407 aren't listed but generally include reactions related to inhaling medication such as coughing or wheezing; however, the trial primarily aims to assess these potential side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have two CFTR gene mutations causing my condition.
Select...
I am 18 years old or older.
Select...
My lung function is between 50% and 100% of what is expected for my age, gender, and height.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate safety and tolerability of KB407 based upon assessment of adverse events (frequency, severity, relatedness), and changes from baseline in physical examinations, vital signs, ECG, and clinical laboratory test results
Secondary outcome measures
To evaluate the effects of KB407 on pulmonary function, as measured by change from baseline in absolute and percent predicted FEV1
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3 (open label)Experimental Treatment1 Intervention
Four administrations of KB407
Group II: Cohort 2 (open label)Experimental Treatment1 Intervention
Two administrations of KB407
Group III: Cohort 1 (open label)Experimental Treatment1 Intervention
A single administration of KB407
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Who is running the clinical trial?
Krystal Biotech, Inc.Lead Sponsor
12 Previous Clinical Trials
418 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
David Chien, MDStudy DirectorSenior Vice President of Clinical Development
6 Previous Clinical Trials
231 Total Patients Enrolled
Brittani Agostini, RN, CCRCStudy DirectorAssociate Director, Clinical Operations, Krystal Biotech
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been vaccinated within 72 hours before starting treatment and have no plans for vaccination during treatment.I have two CFTR gene mutations causing my condition.I haven't been hospitalized or had a significant infection in the last 14 days.I cannot undergo a bronchoscopy as per my doctor's advice.I haven't been treated for specific bacterial infections in the last 3 months.I am 18 years old or older.I haven't started or changed any long-term treatments except for pancreatic enzymes in the last 28 days.I haven't been in another clinical study or taken experimental drugs recently.Your past sweat chloride level was higher than 60 mmol/L.You have had an organ transplant or are on the waiting list for one.I have not had an oral herpes outbreak in the last 30 days.I am willing to follow the study's birth control requirements.I am not pregnant or nursing.I have been diagnosed with cystic fibrosis based on symptoms and tests.You have important abnormal blood or chemistry test results that could affect the study treatment's safety and effectiveness.My lung function is between 50% and 100% of what is expected for my age, gender, and height.Your oxygen level is above 92% when measured at rest without extra oxygen.You have a known allergy to breathing in glycerol.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 (open label)
- Group 2: Cohort 1 (open label)
- Group 3: Cohort 3 (open label)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks could be associated with KB407 (Nebulization) treatments?
"Due to the fact that KB407 (Nebulization) is currently in its first phase of clinical trials, there exists limited evidence of both efficacy and safety. As a result, our team at Power has assigned it a score of 1 on their scale from 1-3."
Answered by AI
Are there opportunities currently available to join this research endeavor?
"As reported on clinicaltrials.gov, the trial posted on November 1st 2022 is not presently recruiting patients. Despite this particular study being in limbo, 412 other trials are currently actively enrolling volunteers right now."
Answered by AI
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