Can a new fertility drug match the real thing?
NCT ID NCT07794683
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests whether an experimental drug called KM04 is absorbed and cleared by the body in the same way as the approved fertility drug Gonal-f. Healthy adult women aged 18 to 40 receive a single dose of each drug in random order, with blood samples taken to compare drug levels. The goal is to see if KM04 could be a similar alternative to Gonal-f.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KM04, an experimental version of the fertility drug follitropin alfa (Gonal-f)
- What this could lead to
- If KM04 behaves like Gonal-f in the body, it could become a more affordable or accessible fertility treatment option.
- What could go wrong
- This is an early, small study in healthy volunteers, not people with fertility issues. Even if the drug matches in healthy women, it may not work the same in patients, and the trial does not test effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant must be 18 to 40 years of age inclusive, at the time of signing the informed consent. 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) at screening. 3. Body weight ≥ 45 kg and body mass index (BMI) within the range 18.0-30.0 kg/m2 (inclusive). 4. Female assigned at birth, inclusive of all gender identities. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (See Section 10.3.1). 5. Administration of combined oral contraceptives for at least 2 consecutive menstrual periods before downregulation and continued until 4 weeks following the last administration of study intervention. 6. Presence of both ovaries. 7. History of regular menstrual cycle (24 to 35 days) prior to the initiation of oral contraceptives. 8. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: 1. Participant is pregnant, breastfeeding, or plans to become pregnant or breastfeed during the course of the study. 2. Sensitivity to any of the study interventions, follicle-stimulating hormone (FSH), lutenizing hormone, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study. 3. History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders. 4. History of previous deep vein thrombosis (DVT), pulmonary embolism or any other thromboembolic or similar events. 5. History or presence of polycystic ovary syndrome or uterine fibroids. 6. History or presence of impaired thyroid function. 7. Evidence of active infection, including chronic or localized infections, by history, physical examination findings, or laboratory data, as determined by the Investigator within 1 week prior to Day 1 of Treatment Period 1. 8. Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment. 9. History or presence of any condition that in the opinion of the investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data. 10. History or presence of drug or alcohol abuse per Investigator's discretion 11. History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. 12. Past or intended use of prescription medication or over-the-counter medication including herbal medications within 4 weeks or 5 half-lives (whichever is longer) prior to dosing. 13. Concurrent enrollment or past participation in another investigational study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within 90 days or 5 half-lives (whichever is longer) before planned first dose of study intervention in this clinical study. 14. FSH level \> 5 IU/ml at Day -23 of Treatment Period 1. 15. Estradiol level \> 90 pg/mL at Day -23 of Treatment Period 1. 16. Presence of ovarian cysts \> 3 cm in diameter at screening or Day -23 of Treatment Period 1, or any other cyst at the Investigator's discretion. 17. Presence of \> 40 follicles at screening or Day -23 of Treatment Period 1. 18. Positive drug/alcohol screen at screening or Day -1. 19. Presence of hepatitis B surface antigen, positive human immunodeficiency virus (HIV), or positive hepatitis C antibody test at screening. 20. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2 x upper limit of normal reference range at screening. 21. Other clinically relevant findings at screening. 22. Unwilling to abstain from alcohol or other prohibited drugs or medications for 48 hours prior to dosing through the duration of each Clinical Research Unit (CRU) visit. 23. Participants will be screened for FSH anti-drug antibodies at prescreening, and subjects found positive above cut-off levels (to be determined during validation) will be excluded from the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.