Badanie mające na celu ocenę farmakokinetyki i bezpieczeństwa stosowania produktu KM04 w porównaniu z produktem Gonal-f RFF Redi-ject zatwierdzonym w Stanach Zjednoczonych i produktem Gonal-f zatwierdzonym w Unii Europejskiej u zdrowych dorosłych ochotników płci żeńskiej

Kryteria wyłączenia kto nie może wziąć udziału (23)

1. Participant is pregnant, breastfeeding, or plans to become pregnant or breastfeed during the course of the study.
2. Sensitivity to any of the study interventions, follicle-stimulating hormone (FSH), lutenizing hormone, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
3. History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders.
4. History of previous deep vein thrombosis (DVT), pulmonary embolism or any other thromboembolic or similar events.
5. History or presence of polycystic ovary syndrome or uterine fibroids.
6. History or presence of impaired thyroid function.
7. Evidence of active infection, including chronic or localized infections, by history, physical examination findings, or laboratory data, as determined by the Investigator within 1 week prior to Day 1 of Treatment Period 1.
8. Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment.
9. History or presence of any condition that in the opinion of the investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data.
10. History or presence of drug or alcohol abuse per Investigator's discretion
11. History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
12. Past or intended use of prescription medication or over-the-counter medication including herbal medications within 4 weeks or 5 half-lives (whichever is longer) prior to dosing.
13. Concurrent enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 90 days or 5 half-lives (whichever is longer) before planned first dose of study intervention in this clinical study.
14. FSH level > 5 IU/ml at Day -23 of Treatment Period 1.
15. Estradiol level > 90 pg/mL at Day -23 of Treatment Period 1.
16. Presence of ovarian cysts > 3 cm in diameter at screening or Day -23 of Treatment Period 1, or any other cyst at the Investigator's discretion.
17. Presence of > 40 follicles at screening or Day -23 of Treatment Period 1.
18. Positive drug/alcohol screen at screening or Day -1.
19. Presence of hepatitis B surface antigen, positive human immunodeficiency virus (HIV), or positive hepatitis C antibody test at screening.
20. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2 x upper limit of normal reference range at screening.
21. Other clinically relevant findings at screening.
22. Unwilling to abstain from alcohol or other prohibited drugs or medications for 48 hours prior to dosing through the duration of each Clinical Research Unit (CRU) visit.
23. Participants will be screened for FSH anti-drug antibodies at prescreening, and subjects found positive above cut-off levels (to be determined during validation) will be excluded from the study.