A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

Phase 1 Completed 70 enrolled Alnylam Pharmaceuticals The Medicines Company · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.

Timeline

Start: 2014-12
Primary completion: 2015-05
Completion: 2015-11

Publications

Fitzgerald K, White S, Borodovsky A, Bettencourt BR, Strahs A, Clausen V, Wijngaard P, Horton JD, Taubel J, Brooks A, Fernando C, Kauffman RS, Kallend D, Vaishnaw A, Simon A. A Highly Durable RNAi Therapeutic Inhibitor of PCSK9. N Engl J Med. 2017 Jan 5;376(1):41-51. doi: 10.1056/NEJMoa1609243. Epub 2016 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Inclisiran	Small interfering RNA (siRNA)	25 mg	Subcutaneous
Comparator	Inclisiran	Small interfering RNA (siRNA)	100 mg	Subcutaneous
Comparator	Inclisiran	Small interfering RNA (siRNA)	125 mg	Subcutaneous
Comparator	Inclisiran	Small interfering RNA (siRNA)	250 mg	Subcutaneous
Comparator	Inclisiran	Small interfering RNA (siRNA)	300 mg	Subcutaneous
Comparator	Inclisiran	Small interfering RNA (siRNA)	500 mg	Subcutaneous
Comparator	Inclisiran	Small interfering RNA (siRNA)	800 mg	Subcutaneous

A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

Summary

Timeline

Publications

Drugs

Indications