FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have been shown to be very similar. This is a trial in healthy Chinese women investigating the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Solution for Injection, subcutaneous administration
First Hospital Affiliated to Nanjing Medical University Jiangsu Province Hospital
Nanjing, China
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)
Area under the concentration-time curve from dosing to infinity.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt)
AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Maximum Serum Concentration Observed (Cmax)
Maximum concentration observed in serum.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed concentration in serum.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Apparent Total Systemic Clearance (CL/F)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Terminal Elimination Half-life (t½)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG)
Number of participants with clinically significant abnormal changes in ECG are presented.
Time frame: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Number of Participants With Clinically Significant Abnormal Changes in Vital Signs
Number of participants with clinically significant abnormal changes in vital signs (systemic blood pressures, heart rate and body temperature) are presented.
Time frame: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Number of participants with clinically significant abnormal findings in laboratory parameters (clinical chemistry, haematology, urinalysis) are presented.
Time frame: At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11)
Number of Participants With Adverse Events (AEs) and Type of AEs
An AE is any untoward medical occurrence in a participant participating in a clinical trial. Number of participants with any AE (serious or non-serious) and type of AEs ( mild, moderate, severe) are presented.
Time frame: From signed informed consent until the end-of-trial visit (Day 28)
Frequency of Injection Site Reactions
The injection site reactions (redness, pain, itching, swelling, and bruising) will be assessed by the investigator after injection, 30 minutes, and 24 hours after administration of the IMP. Each injection site reaction will be assessed as none, mild, moderate, or severe.
Time frame: Immediately, 30 minutes, and 24 hours after administration
Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies
Time frame: On Day 1 predose, Day 7, and Day 28
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