Healthy Female Adult VolunteersPhase 1NCT07794683
A Study to Investigate the Pharmacokinetics and Safety of KM04 Compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in Healthy Adult Female Volunteers
A Phase 1 study testing KM04, Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® and European Union (EU)-Gonal-f® in people with Healthy Female Adult Volunteers, run by Xentria, Inc..
Trial summary
A study to investigate the pharmacokinetics and safety of KM04 compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in healthy adult female volunteers Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Adult Volunteers
- What is being tested?
- KM04, Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® and European Union (EU)-Gonal-f®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 40 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) at screening.
- Body weight ≥ 45 kg and body mass index (BMI) within the range 18.0-30.0 kg/m2 (inclusive).
- 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).
- 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.
- Presence of both ovaries.
- History of regular menstrual cycle (24 to 35 days) prior to the initiation of oral contraceptives.
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participant is pregnant, breastfeeding, or plans to become pregnant or breastfeed during the course of the study.
- 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.
- History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders.
- History of previous deep vein thrombosis (DVT), pulmonary embolism or any other thromboembolic or similar events.
- History or presence of polycystic ovary syndrome or uterine fibroids.
- History or presence of impaired thyroid function.
Show all 23Show fewer
- 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.
- Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment.
- 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.
- History or presence of drug or alcohol abuse per Investigator's discretion
- History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- 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.
- 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.
- FSH level > 5 IU/ml at Day -23 of Treatment Period 1.
- Estradiol level > 90 pg/mL at Day -23 of Treatment Period 1.
- 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.
- Presence of > 40 follicles at screening or Day -23 of Treatment Period 1.
- Positive drug/alcohol screen at screening or Day -1.
- Presence of hepatitis B surface antigen, positive human immunodeficiency virus (HIV), or positive hepatitis C antibody test at screening.
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2 x upper limit of normal reference range at screening.
- Other clinically relevant findings at screening.
- 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.
- 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.
About this study
Official title: A Single Center, Single-Dose, Double-Blind, Randomized, Three-Treatment, Three-Period, Six-Sequence, Crossover Study to Demonstrate Pharmacokinetic Similarity Between KM04, US-Gonal-f® RFF Redi-ject®, EU-Gonal-f®, and to Evaluate Safety in Healthy Adult Female Volunteers
A study to investigate the pharmacokinetics and safety of KM04 compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in healthy adult female volunteers
Read the detailed description
A Single Center, Single-Dose, Double-Blind, Randomized, Three-Treatment, Three-Period, Six-Sequence, Crossover Study to Demonstrate Pharmacokinetic Similarity Between KM04, US-Gonal-f® RFF Redi-ject®, EU-Gonal-f®, and to Evaluate Safety in Healthy Adult Female Volunteers
- Conditions
- Healthy Female Adult Volunteers
- Being tested
- KM04, Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject®, European Union (EU)-Gonal-f®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KM04Drug
Participants will receive a single subcutaneous dose of 300 International Unit (IU) in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.
Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject®Drug
Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.
European Union (EU)-Gonal-f®Drug
Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.
| Study group | Role | What they receive |
|---|---|---|
| KM04 | Experimental | Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods Receives: Drug: KM04 |
| Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® | Active comparator | Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods Receives: Drug: Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® |
| European Union (EU)-Gonal-f® | Active comparator | Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods Receives: Drug: European Union (EU)-Gonal-f® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax)
To compare the Pharmacokinetic (PK) similarity in healthy female participants between KM04, Unites States (US)-Gonal-f revised formulation female (RFF) Redi-ject and European Union (EU)-Gonal-f
Measured: 0 to 192 hours
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
To compare the Pharmacokinetic (PK) similarity in healthy female participants between KM04, Unites States (US)-Gonal-f revised formulation female (RFF) Redi-ject and European Union (EU)-Gonal-f
Measured: 0 to 192 hours
Secondary outcomes (6)
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
To evaluate additional PK parameters of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f
Measured: 0 to 192 hours
Time to Cmax (Tmax)
To evaluate additional PK parameters of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f
Measured: 0 to 192 hours
Terminal half-life (t1/2)
To evaluate additional PK parameters of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f
Measured: 0 to 192 hours
The proportion of participants with a negative baseline anti-drug antibody (ADA) test result and confirmed post dose positive ADA test result at any time during the study
To compare the immune response of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f for the assessment of immunogenicity
Measured: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
The proportion of participants with a negative baseline ADA test result and confirmed post dose positive neutralizing antibody (NAb) result at any time during the study
To compare the immune response of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f for the assessment of immunogenicity
Measured: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
Adverse event (AE) assessments
To assess the safety and tolerability of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f
Measured: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female Adult VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794683
- Sponsor's protocol ID
- KM04-101
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single-Dose, Double-Blind, Randomized, Three-Treatment, Three-Period, Six-Sequence, Crossover Study to Demonstrate Pharmacokinetic Similarity Between KM04, US-Gonal-f® RFF Redi-ject®, EU-Gonal-f®, and to Evaluate Safety in Healthy Adult Female Volunteers
- ClinicalTrials.gov ID
- NCT07794683
- Acronym / sponsor ID
- KM04-101
- Conditions
- Healthy Female Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Xentria, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate the pharmacokinetics and safety of KM04 compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in healthy adult female volunteers
Detailed description
A Single Center, Single-Dose, Double-Blind, Randomized, Three-Treatment, Three-Period, Six-Sequence, Crossover Study to Demonstrate Pharmacokinetic Similarity Between KM04, US-Gonal-f® RFF Redi-ject®, EU-Gonal-f®, and to Evaluate Safety in Healthy Adult Female Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KM04 | Experimental | Drug: KM04Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods |
| Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® | Active comparator | Drug: Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject®Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods |
| European Union (EU)-Gonal-f® | Active comparator | Drug: European Union (EU)-Gonal-f®Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant must be 18 to 40 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG) at screening.
- Body weight ≥ 45 kg and body mass index (BMI) within the range 18.0-30.0 kg/m2 (inclusive).
- 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).
- 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.
Key exclusion criteria (23 listed)
- Participant is pregnant, breastfeeding, or plans to become pregnant or breastfeed during the course of the study.
- 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.
- History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders.
- History of previous deep vein thrombosis (DVT), pulmonary embolism or any other thromboembolic or similar events.
- History or presence of polycystic ovary syndrome or uterine fibroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KM04Participants will receive a single subcutaneous dose of 300 International Unit (IU) in either Treatment Period 1, Treatment Period 2, or Treatment Period 3. | Drug | KM04 |
| Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject®Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3. | Drug | Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® |
| European Union (EU)-Gonal-f®Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3. | Drug | European Union (EU)-Gonal-f® |
Primary outcome
Maximum observed serum concentration (Cmax)
Time frame: 0 to 192 hours
To compare the Pharmacokinetic (PK) similarity in healthy female participants between KM04, Unites States (US)-Gonal-f revised formulation female (RFF) Redi-ject and European Union (EU)-Gonal-f
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: 0 to 192 hours
To compare the Pharmacokinetic (PK) similarity in healthy female participants between KM04, Unites States (US)-Gonal-f revised formulation female (RFF) Redi-ject and European Union (EU)-Gonal-f
6 secondary outcomes
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: 0 to 192 hours
Time to Cmax (Tmax)
Time frame: 0 to 192 hours
Terminal half-life (t1/2)
Time frame: 0 to 192 hours
The proportion of participants with a negative baseline anti-drug antibody (ADA) test result and confirmed post dose positive ADA test result at any time during the study
Time frame: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
The proportion of participants with a negative baseline ADA test result and confirmed post dose positive neutralizing antibody (NAb) result at any time during the study
Time frame: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
Adverse event (AE) assessments
Time frame: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Related trials for Healthy Female Adult Volunteers
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
Recruiting
Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
Aging, Frailty
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
Recruiting
Exploring Resistance Exercise Training Plus High-Intensity Interval Training (ReHIIT) as Cancer Prehabilitation
Healthy Adult Male and Female Volunteers, Intervention
Recruiting
Effects of Exercise Frequency on Muscle Size and Strength in Healthy, Untrained Young Adults
Healthy Adult Male and Female Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KM04, Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® and European Union (EU)-Gonal-f® in people with Healthy Female Adult Volunteers, run by Xentria, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed serum concentration (Cmax) (time frame: 0 to 192 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.