Pharmacokinetics of FSH and hCG After a Single Subcutaneous Injection of Gonadotropins-IBSA

Inclusion Criteria:

1. Female of childbearing potential, non-smoker (no use of tobacco or nicotine productswithin 3 months prior to screening), ≥18 and ≤45 years of age, with BMI >18.5 and <32.0 kg/m2 and body weight ≥45.0 kg.

2. Healthy as defined by:

3. the absence of clinically significant illness and surgery within 4 weeks priorto dosing.

4. the absence of clinically significant history of neurological, endocrine,cardiovascular, respiratory, hematological, immunological, psychiatric,gastrointestinal, renal, hepatic, and metabolic disease.

5. Use of a COC containing at least 20 µg of ethinyl estradiol for at least 3 monthsprior to screening and willing to keep using the same oral contraceptive until theend of the study. The usual regimen (with hormone-free interval or continuousdosing) will be allowed until Day -1. Subjects must agree to take the COC in acontinuous manner (no hormone-free interval) from Day 1 to Day 72.

6. Females who are sexually active with a non-sterile male partner (sterile malepartners are defined as men vasectomized for atleast 3 months prior to dosing) mustbe willing to use a male condom with intravaginally applied spermicide or totalabstinence from heterosexual intercourse (when this is in line with the preferredand usual lifestyle of the subject) from screening and throughout the study and for 30 days after the last study drug administration.

7. Able to understand the study procedures and provide signed informed consent toparticipate in the study

Exclusion Criteria:

1. Any clinically significant abnormal finding at physical examination at screening.

2. Clinically significant abnormal laboratory test results or positive serology testresults for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody,or human immunodeficiency virus (HIV) antigen and antibody at screening.

3. Positive pregnancy test or lactating subject.

4. Positive urine drug screen, urine cotinine test, or alcohol breath test.

5. Known allergic reactions to FSH, hCG, other gonadotropins, or other related drugs,or to any excipient in the formulation.

6. Clinically significant ECG abnormalities or vital signs abnormalities (systolicblood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.

7. History of drug abuse within 1 year prior to screening or recreational use of softdrugs (such as marijuana) within 1 month or hard drugs (such as cocaine,phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetaminederivatives) within 3 months prior to screening.

8. History of alcohol abuse within 1 year prior to screening or regular use of alcoholwithin 6 months prior to screening that exceeds 10 units of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).

9. Hemoglobin <125 g/L, or hematocrit &lt;0.32 L/L at screening.

10. FSH levels > 4 IU/L at admission in each period.

11. Clinically significant history of an abnormal menstrual cycle

12. Abnormal Pap smear prior to administration of the study drug (result is valid for 12months).

13. History of ovarian cysts or enlargement.

14. History or presence of polycystic ovary syndrome.

15. Presence of undiagnosed vaginal and/or urinary tract bleeding.

16. History or presence of sex hormone dependent tumors of reproductive tract andaccessory organs.

17. History of hypothalamus or pituitary gland tumors.

18. Personal history or strong family history (first degree relative) of coagulationdisorders such as thromboembolic diseases (e.g., thrombophlebitis, pulmonaryembolism or coagulation factors deficiency).

19. History of rare hereditary galactose and/or lactose intolerance (e.g., congenitallactase deficiency [CLD] or glucose-galactose malabsorption [GGM]).

20. Tattoos covering the potential study drug injection site or any skin conditions thatwould prevent the injection (e.g., psoriasis, major scar, etc.).

21. Use of medications for the timeframes specified below, except for the subject'sprescribed COC and medications exempted by the Investigator on a case-by-case basisbecause they are judged unlikely to affect the PK profile of the study drug orsubject safety (e.g., topical drug products without significant systemicabsorption):

22. depot injection or implant of any drug within 3 months prior to study drugadministration.

23. prescription medications within 14 days prior to study drug administration;

24. any vaccine, including COVID-19 vaccine, within 14 days prior to study drugadministration;

25. over-the-counter (OTC) products and natural health products (including herbalremedies such as St. John's wort, homeopathic and traditional medicines,probiotics, food supplements such as vitamins, minerals, amino acids, essentialfatty acids, and protein supplements used in sports) within 7 days prior tostudy drug administration, with the exception of the occasional use ofacetaminophen (up to 2 g daily);

26. Participation in a clinical research study involving the administration of aninvestigational or marketed drug or device within 30 days prior to dosing,administration of a biological product in the context of a clinical research studywithin 90 days prior to dosing, or concomitant participation in an investigationalstudy involving no drug or device administration.

27. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL ormore of whole blood within 8 weeks prior to dosing.

28. Any reason which, in the opinion of the Investigator, would prevent the subject fromparticipating in the study.