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
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Placebo
- 2.Take SPL84
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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