A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects (NCT02797847) | Clinical Trial Compass
CompletedPhase 1
A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects
United Kingdom80 participantsStarted 2016-06-07
Plain-language summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC02 in healthy subjects.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Safety of ALN-TTRSC02, evaluated by the proportion of subjects experiencing adverse events (AEs)