NCT06429176
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
- Notable Eligibility criteria expanded, about 27 words
- Trial sites expanded: 3 → 27 locations
- Secondary endpoints: details revised at 3 of 14 entries
Notable Enrollment target: 24 to 64v3 Show 6 more changesShow less
- Primary completion date: Oct 1, 2025 to Oct 1, 2027
- Eligibility criteria expanded, about 315 words
- Primary endpoints: 14 to 13
- Study sites: 2 to 3
- Study completion date: Dec 31, 2025 to Dec 31, 2027
- Secondary endpoints: 11 to 14
- Minor Study sites: 1 to 2
- Start date changed from estimate of Jul 1, 2024 to Jun 24, 2024
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal pulmonary function tests results
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal immunogenicity results
Timeframe: Day 1 through Day 87 (Cohort 1-3) or 108 (Cohort 4)
Secondary (14)
Characterization of pharmacokinetics (PK) of SPL84: maximum serum concentration (Cmax)
Characterization of PK of SPL84: Time to Cmax (Tmax)
Characterization of PK of SPL84: terminal elimination half-life (t1/2)
Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t)
Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞)
Show 9 moreShow less
Characterization of PK of SPL84: Apparent clearance (CL/F)
Characterization of excretion of SPL84: concentration of SPL84 in urine
Efficacy of SPL84 as assessed by change from baseline in percent predicted FEV1
Efficacy of SPL84 as assessed by change from baseline in percent predicted FEF25-75
Efficacy of SPL84 as assessed by change from baseline in Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score
Efficacy of SPL84 as assessed by change from baseline in body weight
Preliminary efficacy of SPL84 as assessed by change from baseline of antibiotic treatment (Cohort 1-3 only)
Cohort 1-3: Safety and Tolerability of SPL84 as assessed by number of participants with abnormal sputum microbiology results Cohort 4: Exploratory efficacy of SPL84 as assessed by number of participants with change in abnormal sputum microbiology result
Exploratory efficacy of SPL84 as assessed by number of participants with change in Lung Clearance Index at 2.5% of starting concentration (LCI2.5)
Arms and interventions
SPL84Active comparator
PlaceboPlacebo comparator
Drugs: SPL84
Other: Placebo
Sites
27 sites in 9 countries
United States 16, Germany 2, Israel 2, Poland 2, Czechia 1, France 1, Italy 1, Lithuania 1, Spain 1