A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects

Launched by ALNYLAM PHARMACEUTICALS · Jun 8, 2016

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects, age 18 to 65 years, inclusive.
• • Body mass index (BMI) ≥18.0 kg/m2 and ≤30 kg/m2 assessed at Screening.
• • No clinically significant health concerns, as determined by medical history and physical examination, in the opinion of the Investigator.
• • Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception, willing and able to comply with the study requirements and to provide written informed consent.
• • For Japanese cohorts, subjects of Japanese descent are defined as people carrying a Japanese passport, descendants of 4 Japanese grandparents, and have not been outside Japan for more than 5 years.
• Exclusion Criteria:
• • Clinically relevant history or presence of respiratory, gastrointestinal, renal, cardiovascular, hepatic, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, and other inflammatory diseases, or dermatological or connective tissue diseases or disorders.
• • Active serious mental illness or psychiatric disorder.
• • Clinically significant ECG abnormalities. Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant.
• • Known history of allergic reaction to an oligonucleotide or GalNAc.
• • History of intolerance to subcutaneous injection.