A Study to Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects
Trial Parameters
Brief Summary
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-1180 after single- and multiple-ascending doses in healthy subjects.
Eligibility Criteria
Inclusion Criteria: * Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive * Body mass index from 19 to 35 kg/m2, inclusive * Estimated glomerular filtration rate ≥ 80 mL/min * Normal liver biochemistry tests * Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance * Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator * Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission * Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception * Must, in the opinion of the investigator, be in good health based upon medical hi