A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants

Not Applicable

Recruiting

• Conditions: Hypogonadism
• Interventions: Drug: Zoladex

• Registration Number: NCT07097259
• Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Brief Summary

The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and 2. At the end of the first Downregulation period (DR1), eligible participants will be randomly assigned to 1 of the 2 treatment sequences:

Sequence 1: Test - Reference Sequence 2: Reference - Test Where, Test = follitropin alfa (solution for injection in prefilled pen), and Reference = follitropin alfa (powder and diluent for solution for injection in vial).

The total duration of the study will be up to approximately 9 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-15
• Study Start: 2025-07-21
• Study First Submitted QC: 2025-07-24
• Study First Posted: 2025-07-31
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-21
• Last Update Posted: 2025-09-25
• Primary Completion: 2025-10-16
• Study Completion: 2025-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
• Have a normal baseline testosterone level
• Have a body weight of more than equal to 60 kilograms and Body Mass Index within the range 18 to 30 kilograms per meter square
• Other protocol defined inclusion criteria could apply

Exclusion Criteria

• Any condition, that, in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.

• Participants using the following within 28 days prior to start of study intervention:

  • Drugs or herbal formulations known to increase testosterone levels (e.g. topical testosterone, sildenafil, fluoxymesterone, herbal remedies containing ginseng)
  • Medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes (e.g. antiarrhythmic, antipsychotics, antidepressants, macrolide and quinine antimicrobials, azole antifungals).

• History of clinically relevant cardiovascular events

• History of tumors of the pituitary gland or hypothalamus

• Smokers

• Other protocol defined exclusion criteria could apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Zoladex	Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2.
Sequence 2	Zoladex	Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2.

Primary Outcome Measures

Name	Time	Method
Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-t, adj) of Follitropin Alfa	Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h (Day 10) after Test/Reference administration
Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf,adj) of Follitropin Alfa	Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration
Baseline Adjusted Maximum Observed Serum Concentration (Cmax,adj) of Follitropin Alfa	Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	Up to Day 34
Occurrence of Abnormalities (Grade >=3) in Vital Signs	Up to Day 34
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity	Up to Day 34
Occurrence of Abnormalities (Grade >=3) in Laboratory Test Values	Up to Day 34
Occurrence of Clinically Significantly Abnormal Electrocardiograms (ECGs)	Up to Day 34
Pharmacokinetic (PK) Plasma Concentrations of Follitropin Alfa	Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration
Number of Participants With Local Tolerability/Injection Site Reactions (ISRs)	Up to Day 34
Number of Participants With Positive Anti-Drug Antibody (ADA) of Follitropin Alfa	Predose: Day 1 (Period 1), Day 25 (Period 2), Day 34 (End of Treatment). ADA positive participants followed until end of study(earliest of ADA negative(baseline) or loss to follow-up (upto 40 months)

Trial Locations

Locations (1)

ICON Early Phase Services, LLC_Clinic San Antonio; 🇺🇸 San Antonio, Texas, United States