Trial of JYB1904 Injection in Adolescent Participants
ConditionAllergic Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-17
SponsorJemincare
About this trial
This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescent study participants (both male and female) who are at least 12 years of age but under 18 years of age at the time of signing the Informed Consent Form (ICF).
History of allergic diseases, including but not limited to food allergies, allergic rhinitis, allergic asthma, and chronic spontaneous urticaria.
Body weight ≥ 30 kg at screening.
Agreement to use effective contraception during the study and for 1 year following administration of the study drug.
Disqualifiers
Patients with a history of hypersensitivity to JYB1904 Injection, its excipients, or any anti-IgE therapy.
Any severe or poorly controlled chronic disease (including but not limited to severe arrhythmia, ischemic heart disease, NYHA Class III/IV left ventricular failure, severe pulmonary disease, poorly controlled asthma, poorly controlled hypertension, poorly controlled diabetes, or poorly controlled hypothyroidism or hyperthyroidism) that, in the investigator's judgment, may compromise the safety of the trial participant.
History of severe allergic reactions, such as anaphylactic shock.
History of blood phobia, needle phobia, or difficulty with venipuncture; or abnormal skin at the administration site that may interfere with drug administration or the investigator's assessment (e.g., skin lesions, rashes, tattoos, etc.).
Trial design
Design model
Single group
Treatments tested in this trial
JYB1904
DrugReceived a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: JYB1904 Injection GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
Pharmacokinetic (PK) profile of JYB1904 injection
Maximum Concentration(Cmax）
Time frame
Through study completion, an average of 28 weeks3
Pharmacokinetic (PK) profile of JYB1904 injection
Time to Reach Cmax（Tmax）
Time frame
Through study completion, an average of 28 weeks4
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 weeksSecondary outcomes
1
Other PK Parameters
Terminal Phase Half-life（ t1/2）
Time frame
Through study completion, an average of 28 weeks2
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 weeks3
Pharmacodynamic (PD) profile of JYB1904 injection
Changes in serum level of total and free IgE
Time frame
Through study completion, an average of 28 weeks4
Immunogenicity of JYB1904 injection
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 weeksLocations
Source ClinicalTrials.gov
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