This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGIncidence of adverse events, serious adverse and abnormal laboratory values event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Time frame: An average of 1 year
Maximum measured plasma concentration (Cmax) of TWP-201;
Time frame: 28 days
Time to maximum plasma concentration (Tmax) of TWP-201;
Time frame: 28 days
Half-life (T1/2) of TWP-201.
Time frame: 28 days
Pharmacodynamics(PD).
Determination of serum concentrations of FSH, E2 and LH after dosing.
Time frame: 28 days
Pharmacodynamics(PD).
The number of follicles after dosing. The size of follicles after dosing.
Time frame: 28 days
Immunogenicity profile of TWP-201.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Time frame: 28 days
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