Phase I ReferenceA PK-study
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
The citations are from ClinicalTrials.com ( https://clinicaltrials.gov/ct2/show/record/NCT02264639 ). The study identifier is ClinicalTrials.gov Identifier: NCT02264639.
An Open Label, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL-2 as an Add-On to Standard of Care in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH).
This study will be the initial exploration of pegcetacoplan in patients with PNH. The assessments of the safety, tolerability, PK, and PD following administration of single and multiples doses of pegcetacoplan will guide decisions to further develop the drug.
Planimeter was in charge for the eCRF, complete data management, statistical evaluation and reporting.