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

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Treatments

Drug: Sterile Normal Saline (0.9% NaCl)

Drug: ALN-CC5

Study type

Interventional

Funder types

Industry

Identifiers

NCT02352493

ALN-CC5-001

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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