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

NCT06781957 | Completed Phase 1

• 1 other identifier: 23CDN-FCG08
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study is to evaluate the PK and the dose-proportionality of FSH and HCG following a single dose of Gonadotropins-IBSA, administered subcutaneously.

Conditions

OVARIAN STIMULATION; Infertility

Keywords

gonadotropin; FSH; hCG; infertility; Controlled ovarian stimulation

Outcome Measures

Primary Outcomes (6)

• Primary PK endpoints FSH

  Day 72: AUC0-24

  until 240 hours post dose

• Primary PK endpoints hCG

  Day 72: AUC0-24

  until 240 hours post dose.

• Dose-proportionality of FSH

  AUC (using baseline-corrected data)

  until 240 hours post dose

• Dose-proportionality of FSH

  Cmax (using baseline-corrected data)

  until 240 hours post dose

• Dose-proportionality of hCG

  AUC (baseline correction)

  until 240h post dose

• Dose-proportionality of hCG

  Cmax (baseline correction)

  until 240h post dose

Secondary Outcomes (3)

• PD endpoints of Gonadotropins-IBSA

  until 240 hours post dose

• PD endpoints of Gonadotropins-IBSA

  until 240 hours post dose

• Adverse events (AEs)

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

Study Arms (3)

Gonadotropins 75 IU

EXPERIMENTAL

Single dose 75 IU

Drug: Gonadotropins Subcutaneos

Gonadotropins 225 IU

EXPERIMENTAL

Single dose 225 IU

Drug: Gonadotropins Subcutaneos

Gonadotropins 450 IU

EXPERIMENTAL

Single dose 450 IU

Drug: Gonadotropins Subcutaneos

Interventions

Gonadotropins Subcutaneos DRUG

Gonadotropins s.c. single dose

Gonadotropins 225 IU; Gonadotropins 450 IU; Gonadotropins 75 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 72.
• Females who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for atleast 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%).
• Hemoglobin \<125 g/L, or hematocrit \&lt;0.32 L/L at screening.
• FSH levels \> 4 IU/L at admission in each period.
• 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 17, 2025
• Study Start: September 15, 2024
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)