This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases.
This Study is a multicenter, single-arm, Phase Ib clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of JYB1904 injection in adolescent participants aged 12-17 years
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1
Safety and Tolerability
Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results
Time frame: Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection
Maximum Concentration(Cmax)
Time frame: Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection
Time to Reach Cmax(Tmax)
Time frame: Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection
Area Under the concentration-time Curve from time zero to the last accurately quantifiable time point(AUC0-t)
Time frame: Through study completion, an average of 28 weeks
Other PK Parameters
Terminal Phase Half-life( t1/2)
Time frame: Through study completion, an average of 28 weeks
Other PK Parameters
Area Under the concentration-time Curve from time zero to infinity(AUC0-inf)
Time frame: Through study completion, an average of 28 weeks
Pharmacodynamic (PD) profile of JYB1904 injection
Changes in serum level of total and free IgE
Time frame: Through study completion, an average of 28 weeks
Immunogenicity of JYB1904 injection
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Positive detection rate of anti-drug antibodies (ADA)/neutralizing ADA (Nab), ADA onset time, duration, and titer
Time frame: Through study completion, an average of 28 weeks