Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women

This is a Phase I, open label, sequential, single ascending dose (SAD) study to evaluate the pharmacokinetic (PK), safety, and tolerability of Letrozole LEBE in healthy post-menopausal women.

Inclusion Criteria: * Healthy post-menopausal women. * Capable of providing informed consent. * Weight of ≥50 kg and a BMI ≥19 and ≤39 kg/m2. * Subjects should be able to communicate with clinic staff. Exclusion Criteria: * Subjects who have a history of allergy or hypersensitivity to letrozole or any of the inactive ingredients. * Subjects who have a history of galactose intolerance, severe hereditary lactase deficiency glucose-galactose malabsorption. * Subjects who have used estrogen or progesterone hormone replacement therapy, thyroid replacement therapy, oral contraceptives, androgens, luteinizing hormone (LH) releasing hormone analogs, prolactin inhibitors, or antiandrogens within prior to Screening. * Subjects who have used: any medications including St. John's wort or any medications or products known to be potent or moderate inhibitors of CYP P450 3A4. * Subjects who have been diagnosed with osteoporosis. * Subjects who have an abnormality at Screening or prior to first dose that in the opinion of the investigator increases the risk of participating in the study. * Subjects who have any clinically significant abnormal physical examination or laboratory safety findings at screening. * Subjects who have relevant diseases or clinically significant abnormal relevant findings at Screening, as determined by medical history, physical examination, laboratory, ECG, DEXA, and breast and pelvic examination. * Subjects who have history of any significant chronic disease. * History of cancer within the past 5 years with the exception of non-melanoma skin cancer. * Subjects who have a history of drug-dependence, and recent history of alcoholism or abuse of alcohol. * Subjects who have received a drug in research or have participated in other clinical trials within 90 days, prior to dosing. * Any other unspecified reason that, in the opinion of the investigator (or designee) or sponsor, makes the subject unsuitable for enrolment.