Trial of JYB1904 Injection in Adolescent Participants

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Diseases
• Intervention / Treatment: Drug: JYB1904

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

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jing Xu; Phone Number: 021-58306003; Email: xujing2@jeyoupharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JYB1904 Injection Group; 300 mg JYB1904 injection administered subcutaneously(SC)	Drug: JYB1904; Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results	Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection	Maximum Concentration(Cmax）	Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection	Time to Reach Cmax（Tmax）	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）	Through study completion, an average of 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other PK Parameters	Terminal Phase Half-life（ t1/2）	Through study completion, an average of 28 weeks
Other PK Parameters	Area Under the concentration-time Curve from time zero to infinity（AUC0-inf）	Through study completion, an average of 28 weeks
Pharmacodynamic (PD) profile of JYB1904 injection	Changes in serum level of total and free IgE	Through study completion, an average of 28 weeks
Immunogenicity of JYB1904 injection	Positive detection rate of anti-drug antibodies (ADA)/neutralizing ADA (Nab), ADA onset time, duration, and titer	Through study completion, an average of 28 weeks

Collaborators and Investigators

• Sponsor: Jemincare
• Investigators: Principal Investigator: Liming Wu, First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Estimated): May 17, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Allergic Diseases
• Other Study ID Numbers: JYB1904-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No