drugset / Trial / NCT02264639
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2015-02-23
- Primary completion
- 2018-10-22
- Completion
- 2018-10-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegcetacoplan | Peptide | 5 mg | — |
| Subject | Pegcetacoplan | Peptide | 30 mg | — |
| Subject | Pegcetacoplan | Peptide | 180 mg | — |
| Subject | Pegcetacoplan | Peptide | 270 mg | — |