A Phase 1 interventional study of KM04 and Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject® in Healthy Female Adult Volunteers, sponsored by Xentria, Inc.. Not yet recruiting. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Xentria, Inc. · Phase 1, Interventional, and Other
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 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
Exclusion Criteria:
Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods
Drug: KM04
Participants receive a single subcutaneous dose of each study intervention over 3 treatment periods
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
Drug: European Union (EU)-Gonal-f®
Participants will receive a single subcutaneous dose of 300 International Unit (IU) in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.
Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.
Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.
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
Time frame: 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
Time frame: 0 to 192 hours
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
Time frame: 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
Time frame: 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
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
To compare the immune response of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f for the assessment of immunogenicity
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
To compare the immune response of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f for the assessment of immunogenicity
Time frame: 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
Time frame: Baseline to the End-of-Study (EOS) visit, approximately 12 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Xentria, Inc.