A Phase 1, Multiple-Ascending Dose Study of 2-Methoxyestradiol in Healthy Non-Pregnant Female Participants

The primary objective of this study is to evaluate the pharmacokinetics of multiple ascending doses of 2-methoxyestradiol in healthy, non-pregnant female participants. Assessing the drug's kinetic profile is essential for determining its metabolic behavior and systemic exposure patterns. There are no secondary objectives reported.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 30 years. The cohort includes females and represents a vulnerable population. No medical conditions are reported for the subjects.

This Phase 1 study is designed as a multiple-ascending dose trial evaluating 2-Methoxyestradiol in healthy non-pregnant female participants. The research methodology involves a sequential administration of increasing doses to assess safety and tolerability. The study protocol includes a screening visit to confirm eligibility, followed by scheduled study visits for dose administration and monitoring. An end-of-study visit is conducted to complete the final assessment. The total duration of participant involvement is determined by the specific dosing schedule. Early termination from the study may occur due to predefined safety criteria or withdrawal of consent.

No efficacy assessment parameters, methods, or instruments are specified in the provided documentation.