Allergic DiseasesPhase 1NCT07513857
Trial of JYB1904 Injection in Adolescent Participants
A Phase 1 study testing JYB1904 in people with Allergic Diseases, run by Jemincare.
Trial summary
This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Allergic Diseases
- What is being tested?
- JYB1904
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2026to 30 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
This Phase Ib Trial is Meant to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of JYB1904 Injection in Adolescent Participants With Allergic Diseases.
Read the 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
- Conditions
- Allergic Diseases
- Being tested
- JYB1904
- Keywords
- Allergic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYB1904Drug
Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1
| Study group | Role | What they receive |
|---|---|---|
| JYB1904 Injection Group | Experimental | 300 mg JYB1904 injection administered subcutaneously(SC) Receives: Drug: JYB1904 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results
Measured: Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection
Maximum Concentration(Cmax）
Measured: Through study completion, an average of 28 weeks
Pharmacokinetic (PK) profile of JYB1904 injection
Time to Reach Cmax（Tmax）
Measured: 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）
Measured: Through study completion, an average of 28 weeks
Secondary outcomes (4)
Other PK Parameters
Terminal Phase Half-life（ t1/2）
Measured: Through study completion, an average of 28 weeks
Other PK Parameters
Area Under the concentration-time Curve from time zero to infinity（AUC0-inf）
Measured: Through study completion, an average of 28 weeks
Pharmacodynamic (PD) profile of JYB1904 injection
Changes in serum level of total and free IgE
Measured: 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
Measured: Through study completion, an average of 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start17 May 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic DiseasesStudies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liming Wu, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513857
- Sponsor's protocol ID
- JYB1904-102
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07513857
- Acronym / sponsor ID
- JYB1904-102
- Conditions
- Allergic Diseases
- Keywords
- Allergic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 17 May 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JYB1904 Injection Group | Experimental | Drug: JYB1904300 mg JYB1904 injection administered subcutaneously(SC) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JYB1904Received a single 300 mg JYB1904 injection administered subcutaneously(SC) at D1 | Drug | JYB1904 Injection Group |
Primary outcome
Safety and Tolerability
Time frame: Through study completion, an average of 28 weeks
Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results
Pharmacokinetic (PK) profile of JYB1904 injection
Time frame: Through study completion, an average of 28 weeks
Maximum Concentration(Cmax）
Pharmacokinetic (PK) profile of JYB1904 injection
Time frame: Through study completion, an average of 28 weeks
Time to Reach Cmax（Tmax）
Pharmacokinetic (PK) profile of JYB1904 injection
Time frame: Through study completion, an average of 28 weeks
Area Under the concentration-time Curve from time zero to the last accurately quantifiable time point（AUC0-t）
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liming Wu principal investigator
First People's Hospital of Hangzhou
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JYB1904 in people with Allergic Diseases, run by Jemincare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Xu (021-58306003, xujing2@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Through study completion, an average of 28 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.