Status:
COMPLETED
A Phase 1, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC (Revusiran) in Healthy Volunteers
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
TTR-mediated Amyloidosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.
Eligibility Criteria
Inclusion
- Body mass index (BMI) must be ≥ 16.5 kg/m2 and ≤ 35.0 kg/m2;
- Female subjects must be of non-childbearing potential; e.g., postmenopausal or pre-menopausal with surgical sterilization;
- Male subjects agree to use appropriate contraception;
- Adequate blood counts, liver and renal function;
- Non-smokers for at least 3 months;
- Willing to give written informed consent and are willing to comply with the study requirements;
- Subject was born in Japan and has lived outside of Japan for \<10 years, and subject's biological parents and grandparents are fully Japanese and were born in Japan (cohorts 19 and 20).
Exclusion
- Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
- Subjects with a history of multiple drug allergies or intolerance to SC injection;
- History of drug abuse and/or alcohol abuse;
- Receiving an investigational agent within 3 months prior to study drug administration;
- Considered unfit for the study by the Principal Investigator.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01814839
Start Date
March 1 2013
End Date
May 1 2015
Last Update
February 5 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Site
Leeds, United Kingdom, LS2 9LH
2
Clinical Site
London, United Kingdom, NW10 7EW