Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT03647228
Eligibility Criteria:
Inclusion Criteria (Healthy Volunteers)
1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method
3. Willing to refrain from strenuous exercise/activity for at least 72 hours prior to study visits
4. Body mass index (BMI) \< 35 kg/m2 with a minimum weight of 45 kg
5. Normal diffusing capacity in the lung (≥ 80% predicted) at Screening
Exclusion Criteria (Healthy Volunteers)
1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to:
1. Urine protein/creatinine (P/C) ratio ≥ 0.2 mg/mg
2. Positive test (including trace) for blood on urinalysis
3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, alkaline phosphatase (ALP), serum creatinine, blood urea nitrogen (BUN), fasting blood glucose, potassium \> upper limit of normal (ULN)
4. Platelet count \< LLN
2. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
3. Respiratory infection within 4 weeks of Study Day 1
4. Presence or past history of CS chronic respiratory disease, including any current history (or within 2 years) of asthma. History of allergic rhinitis is acceptable
5. Forced expiratory volume in 1 second (FEV1) \< 80% of predicted at Screening or an FEV1/FVC ratio of \< 0.7
6. Smoking of a tobacco or nicotine-containing product within the previous 6 months (use of a nicotine patch is permitted) or a smoking history of ≥ 10 pack years
7. Any CS finding on chest radiograph
8. Uncontrolled hypertension (blood pressure \[BP\] \> 160/100 mm Hg) at Screening
9. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer
10. Any history of previous treatment with an oligonucleotide
11. Regular use of alcohol within 6 months prior to screening or hard drugs within 1 year prior to screening, or positive urine drug screen at Screening
12. Blood donation of 50 to 499 mL within 30 days of screening or of \> 499 mL within 60 days of screening
Inclusion Criteria (Cystic Fibrosis Participants)
1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject's non-pregnant female partner must be using a highly effective contraceptive method
3. Confirmed diagnosis of CF by seat chloride and/or genetics by referring clinician
4. FEV1 \>/= 50% of predicted
5. Stable CF disease as judged by the Investigator
6. Weight \> 40 kg
Exclusion Criteria (Cystic Fibrosis Participants)
1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to:
1. Abnormal liver function defined as \> 2 times upper limit of normal (ULN) for bilirubin, or 3 time ULN for ALT, AST, or alkaline phosphatase
2. Platelet count \< LLN
2. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
3. Respiratory infection within 4 weeks of Study Day 1
4. Colonization with Burkholderia cepacia or M. abscessus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03647228
Study Brief:
Protocol Section:
NCT03647228