Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis
Phase 2
24
about 1.5 years
18+
2 sites in MA, OH
About this study
Researchers are testing the safety and effectiveness of a drug called SPL84 for adults with cystic fibrosis. The trial will also examine how the body processes the drug and determine if it helps treat CF.
Based on ClinicalTrials.gov records.
What participants do
- 1.Placebo
- 2.Take SPL84
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
Primary: Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal immunogenicity results, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings, Safety and Tolerability of SPL84 as assessed by number of participants with abnormal pulmonary function tests results
Secondary: Characterization of PK of SPL84: Apparent clearance (CL/F), Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞), Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t), Characterization of PK of SPL84: Time to Cmax (Tmax), Characterization of PK of SPL84: terminal elimination half-life (t1/2), Characterization of pharmacokinetics (PK) of SPL84: maximum serum concentration (Cmax), Preliminary efficacy of SPL84 as assessed by change from baseline in Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score, Preliminary efficacy of SPL84 as assessed by change from baseline in body weight
Respiratory