Cystic Fibrosis
Conditions
Brief summary
AEs, adverse events of special interest (AESIs), and serious adverse events (SAEs) (incidence, severity, dose relationship)., Changes from baseline in vital signs and physical examinations., Changes from baseline in laboratory test results., Evaluation for bronchospasm (changes from pre-dose to post-dose FEV1).
Detailed description
Plasma pharmacokinetics of ARCT-032 based on the observed concentrations of mRNA-[CCI] in plasma after single and multiple doses of ARCT-032., Mean absolute change from baseline in pre-dose percent predicted FEV1 on Day [CCI] of the treatment period., Change from baseline in Cystic Fibrosis Questionnaire – Revised Respiratory Symptoms Scale (CFQ-R RSS) score on Day [CCI].
Interventions
None listed
Sponsors
Arcturus Therapeutics Europe B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, adverse events of special interest (AESIs), and serious adverse events (SAEs) (incidence, severity, dose relationship)., Changes from baseline in vital signs and physical examinations., Changes from baseline in laboratory test results., Evaluation for bronchospasm (changes from pre-dose to post-dose FEV1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetics of ARCT-032 based on the observed concentrations of mRNA-[CCI] in plasma after single and multiple doses of ARCT-032., Mean absolute change from baseline in pre-dose percent predicted FEV1 on Day [CCI] of the treatment period., Change from baseline in Cystic Fibrosis Questionnaire – Revised Respiratory Symptoms Scale (CFQ-R RSS) score on Day [CCI]. | — |
Countries
Greece, Poland
Outcome results
None listed