A Phase I Pharmacokinetic and Safety Study Comparing KM04 to Recombinant Human Follicle-Stimulating Hormone in Healthy Adult Female Volunteers

The primary objective of this study is to evaluate the pharmacokinetics and safety of KM04 in comparison to US-Gonal-f RFF Redi-ject and EU-Gonal-f. This investigation is conducted in healthy adult female volunteers to characterize the absorption, distribution, metabolism, and excretion profiles of the investigated product relative to established reference biologics. 6, 4

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers who are female and categorized within the vulnerable population group. The participants fall within age range 3. The study pertains to individuals with functional female infertility.

This Phase 2 clinical trial is designed to investigate the pharmacokinetics and safety of KM04 in comparison to US-Gonal-f RFF Redi-ject and EU-Gonal-f. The study involves healthy adult female volunteers. The research methodology includes a screening visit to assess eligibility, followed by subsequent study visits to monitor physiological responses and drug performance. The sequence of procedures concludes with an end-of-study visit. The overall duration of the trial is estimated to span from February 2026 to June 2026. Early termination from the study may occur based on predefined clinical criteria or safety protocols.

The assessment of efficacy in this study focuses on the management of functional female infertility. The evaluation is conducted within the framework of a phase 2 clinical trial.