Overview
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
Status:
Completed
Completed
Trial end date:
2017-08-01
2017-08-01
Target enrollment:
0
0
Participant gender:
All
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 PNHPhase:
Phase 1/Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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