Status
Completed
Phase
Phase 1
Enrollment
55
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
COMBINATION_PRODUCT
It is a solution for injection in prefilled pen. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of at least 23 days will be maintained between period 1 and 2.
DRUG
It is a powder and diluent for solution for injection in multidose vial. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of 23 days will be maintained between period 1 and 2.
DRUG
It is a auxiliary medicinal product. Participants will receive Zoladex injection on Day -11 in down regulation period, and on Day 17 prior to the start of Period 2.
Timeline
First posted
Jul 31, 2025
Study start
Jul 21, 2025
Primary completion
Dec 23, 2025
Study completion
Dec 23, 2025
Results posted
Not reported
Registry updated
Feb 24, 2026
Outcomes
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
Time frame · 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
Time frame · 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
Time frame · 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 Treatment-Emergent Adverse Events (TEAEs)
Time frame · Up to Day 37
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
Time frame · Up to Day 37
Occurrence of Abnormalities (Grade >=3) in Laboratory Test Values
Time frame · Up to Day 37
Occurrence of Abnormalities (Grade >=3) in Vital Signs
Time frame · Up to Day 37
Occurrence of Clinically Significantly Abnormal Electrocardiograms (ECGs)
Time frame · Up to Day 37
Number of Participants With Local Tolerability/Injection Site Reactions (ISRs)
Time frame · Up to Day 37
Pharmacokinetic (PK) Plasma Concentrations of Follitropin Alfa
Time frame · 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 Positive Anti-Drug Antibody (ADA) of Follitropin Alfa
Time frame · Predose: Day 1 (Period 1), Day 28 (Period 2), Day 37 (End of Treatment). ADA positive participants followed until end of study(earliest of ADA negative(baseline) or loss to follow-up (upto 40 months)
Eligibility
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
ICON Early Phase Services, LLC_Clinic San Antonio
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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