NCT02352493

A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH

A Phase 1/2 Single-ascending and Multiple-ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-CC5 in Healthy Adult Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH

Conditions

• Paroxysmal Nocturnal Hemoglobinuria (PNH)

Interventions

Type	Name	Description
DRUG	ALN-CC5	Single or multiple doses of ALN-CC5 by subcutaneous (sc) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	calculated volume to match active comparator

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-04-01
• Completion: 2017-08-01
• First posted: 2015-02-02
• Last updated: 2020-03-30
• Results posted: 2020-03-30

Locations

4 sites across 2 countries: Spain, United Kingdom