Pharmacokinetics of FSH and hCG Following Multiple Dose of Gonadotropins-IBSA.

NCT06659692 | Completed Phase 1

• 1 other identifier: 23CDN-FCG09
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacokinetics of FSH and hCG after multiple subcutaneous injection of Gonadotropins-IBSA.

Conditions

Ovarian Stimulation; Infertility

Outcome Measures

Primary Outcomes (7)

• Primary PK endpoints

  Day 20: AUC0-24

  until 240 hours post dose.

• Primary PK endpoints

  Day 20:Cmax: to assess the bioavailability of the test product in terms of rate (baseline-corrected, dose-normalised Cmax) of Gonadotropins-IBSA absorption after multiple s.c. injection to healthy female subjects.

  until 240 hours post dose.

• Primary PK endpoints

  Day 20: Tmax (Time to achieve Cmax)

  until 240 hours post dose.

• Primary PK endpoints

  Day 26: AUC0-24

  until 240 hours post dose.

• Primary PK endpoints

  Day 26: Cmax: to assess the bioavailability of the test product in terms of rate (baseline-corrected, dose-normalised Cmax) of Gonadotropins-IBSA absorption after multiple s.c. injection to healthy female subjects.

  until 240 hours post dose.

• Primary PK endpoints

  Day 26: Tmax (Time to achieve Cmax)

  until 240 hours post dose.

• Primary PK endpoints

  Accumulation potential: Rac

  Through the duration of the study

Secondary Outcomes (11)

• Inhibin B

  until 240 hour post last dose

• Estradiol (E2)

  until 240 hour post last dose.

• Number of Follicle

  After seven days of treatment

• Adverse events (AEs)

  From the signature of the Informed Consent until the end of the study.

• Immunogenicity

  At pre-dose on Day 20.

Study Arms (2)

Gonadotropins 150 IU

EXPERIMENTAL

150 IU daily for 7 days.

Drug: Gonadotropins Subcutaneous

Gonadotropins 300 IU

EXPERIMENTAL

300 IU daily for 7 days

Drug: Gonadotropins Subcutaneous

Interventions

Gonadotropins Subcutaneous DRUG

Gonadotropins s.c. multiple dose

Gonadotropins 150 IU; Gonadotropins 300 IU

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female of childbearing potential, non-smoker (no use of tobacco or nicotine products within 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.
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Use of a COC containing at least 20 µg of ethinyl estradiol for at least 3 months prior to screening and willing to keep using the same oral contraceptive until the end of the study. The usual regimen (with hormone-free interval or continuous dosing) will be allowed until Day -1. Subjects must agree to take the COC in a continuous manner (no hormone-free interval) from Day 1 to Day 36.
• Females who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to dosing) must be willing to use a male condom with intravaginally applied spermicide or total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the subject) from screening and throughout the study and for 30 days after the last study drug administration.
• Able to understand the study procedures and provide signed informed consent to participate in the study

You may not qualify if:

• Any clinically significant abnormal finding at physical examination at screening.
• Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
• Positive pregnancy test or lactating subject.
• Positive urine drug screen, urine cotinine test, or alcohol breath test.
• Known allergic reactions to FSH, hCG, other gonadotropins, or other related drugs, or to any excipient in the formulation.
• Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood 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.
• History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
• History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 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%).
• FSH levels \> 4 IU/L at admission in each period.
• Presence of ovarian cysts \> 10 mm in size or clinically significant ovarian enlargement at admission (Day 19).
• Clinically significant history of an abnormal menstrual cycle.
• Abnormal Pap smear prior to administration of the study drug (result is valid for 12 months).
• History of ovarian cysts or enlargement.
• History or presence of polycystic ovary syndrome.
• Presence of undiagnosed vaginal and/or urinary tract bleeding.

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (1)

Syneos Health

Québec, Quebec, GIP 0A2, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 26, 2024
• Study Start: October 10, 2024
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)