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NCT06995482
The goal of this clinical trial is to evaluate if KSHN001034 demonstrates safety, tolerability, and a comparable pharmacokinetic (PK) profile to the reference product, Faslodex® (fulvestrant), which is used for the treatment of hormone receptor-positive breast cancer. Participants will: Receive either the test product (KSHN001034) or the reference product (Faslodex®) administered intramuscularly (IM) or subcutaneously (SC) at doses of low, medium, or high , with doses conducted in 5 cohorts and these participants will be healthy postmenopausal female volunteers. Dosing will be administered in a sequential cohort-wise manner across five cohorts, with DSMB oversight for safety monitoring and dose escalation. Primary Endpoint: Safety and tolerability will be assessed based on the occurrence, severity, and relationship of adverse events (AEs), including serious adverse events (SAEs). Secondary Endpoint: Pharmacokinetic (PK) parameters will be evaluated, including Cmax (maximum concentration), Tmax (time to maximum concentration), AUC (area under the curve), and T1/2 (half-life).
NCT06983925
To evaluate the pharmacokinetic (PK) characteristics of GS1-144 tablets and the relative bioavailability of the two preparations in healthy postmenopausal female subjects in China.
NCT04000815
Recent studies have shown that C natriuretic peptide (CNP) is produced from granulosa cells, increasing cumulative guanosine monophosphate (cGMP) production by affecting cumulus cells through natriuretic peptide receptors.It has been suggested that the transport of cGMP to oocyte via gap junctions causes a continuous increase in cyclic adenosine monophosphate (cAMP) levels within the oocyte. An important role of increased cAMP levels in oocyte is shown to suppress meiotic progression. Deoxyribonucleic acid (DNA) studies in animals have shown that expression of the natriuretic peptide precursor increases during the periovulatory period and shows that this increase decreases rapidly after Luteinizing hormone(LH) / human chorionic(hCG) stimulation. Human studies have shown that after ovulation induction, the CNP level in follicular fluid decreases following ovulatory dose of hCG (9).