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Not yet recruiting NCT07513857

Trial of JYB1904 Injection in Adolescent Participants

Phase I Interventional Allergic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JYB1904.
Who it may be relevant to
Registry conditions: Allergic Diseases. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases.

Detailed description

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

Interventions

  • Drug JYB1904
    Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1

Primary outcome measures

  • Safety and Tolerability [Time frame: Through study completion, an average of 28 weeks]
  • Pharmacokinetic (PK) profile of JYB1904 injection [Time frame: Through study completion, an average of 28 weeks]
  • Pharmacokinetic (PK) profile of JYB1904 injection [Time frame: Through study completion, an average of 28 weeks]
  • Pharmacokinetic (PK) profile of JYB1904 injection [Time frame: Through study completion, an average of 28 weeks]
Secondary outcome measures (4)
  • Other PK Parameters [Time frame: Through study completion, an average of 28 weeks]
  • Other PK Parameters [Time frame: Through study completion, an average of 28 weeks]
  • Pharmacodynamic (PD) profile of JYB1904 injection [Time frame: Through study completion, an average of 28 weeks]
  • Immunogenicity of JYB1904 injection [Time frame: Through study completion, an average of 28 weeks]

Eligibility criteria

Inclusion criteria

  • 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.
  • The trial participant and their parent or legal guardian are able to understand and voluntarily sign the Informed Consent Form, and are able to comply with study visits and related procedures.

Exclusion criteria

  • 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.).
  • Total blood loss or blood donation of ≥400 mL within 12 weeks prior to screening, or receipt of a blood transfusion within 12 weeks prior to screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07513857 · JYB1904-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗