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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Adequate complete blood counts, liver and renal function

• 12-lead electrocardiogram (ECG) within normal limits

• Female subjects of child bearing potential agreeing to use a protocol specified method of contraception

• Male subjects agreeing to use protocol specified methods of contraception

• Willing to provide written informed consent and willing to comply with study requirements

Exclusion Criteria:

• Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk

• Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study

• History of multiple drug allergies or intolerance to subcutaneous injection

• Parts A and B of the study: Used prescription medications within 14 days or 7 half-lives of administration of the first dose of study drug.

• History of meningococcal infection