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
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).
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.
Crossover
KM04
DrugParticipants 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®
DrugParticipants 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®
DrugParticipants 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
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
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 to Cmax (Tmax)
To evaluate additional PK parameters of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f
Terminal half-life (t1/2)
To evaluate additional PK parameters of KM04, US-Gonal-f RFF Redi-ject, and EU-Gonal-f
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
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This trial is not recruiting at the moment. You can still explore other options:
