Evidence map›Paper›PMID 40504164›Full record

Trial reportClinical and translational science2025

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single-Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double-Blind, Placebo-Controlled Study.

Zhen-Wei Shen, Ting-Han Jin, Kai-Qi Wu, Jie Zhao, Qi Jiang, Tong Guo, Liang Li, Xiao-Hua Feng, Pei-Pei Liu, Gui-Ling Chen

Abstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Emerging IgE and non-IgE targeted therapies for chronic urticaria.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Zhen-Wei ShenDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.
Ting-Han JinDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.
Kai-Qi WuDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.
Jie ZhaoDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.
Qi JiangDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.
Tong GuoDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.
Liang LiShanghai Jemincare Pharmaceutical co., Ltd., Shanghai, P. R. China.
Xiao-Hua FengShanghai Jemincare Pharmaceutical co., Ltd., Shanghai, P. R. China.
Pei-Pei LiuShanghai Jemincare Pharmaceutical co., Ltd., Shanghai, P. R. China.
Gui-Ling ChenDepartment of Phase 1 Clinical Research Center, Shulan (Hangzhou) Hospital, Shulan International Medical College, Zhejiang Shuren University, Hangzhou, P. R. China.ORCID 0009-0004-7343-6996

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Allergic asthma, characterized by airborne allergen sensitivity and Th2 immune responses, is a common and increasing global health concern. Omalizumab, while effective, has limitations such as weight- and IgE-dependent dosing regimens. JYB1904, a recombinant anti-IgE humanized monoclonal antibody (IgG1 subtype), showed superior preclinical properties. We performed a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase Ia trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of JYB1904 in healthy adult participants across five dose levels (range: 75-600 mg; subcutaneously). JYB1904 was well tolerated, with no serious adverse events or safety concerns beyond those observed with omalizumab. Immunogenicity risk was low. PK analysis revealed approximately dose-proportional parameters and an extended half-life (2.5 times that of omalizumab). PD results showed significant free IgE suppression, with JYB1904 demonstrating stronger activity than omalizumab at equivalent doses. JYB1904 offers promising clinical advantages over omalizumab, including extended dosing intervals and enhanced efficacy, warranting further investigation for allergic asthma treatment.

Indexed as

Antibodies, Monoclonal, HumanizedAdolescentAdultAsthmaChinaDose-Response Relationship, DrugDouble-Blind MethodEast Asian PeopleFemaleHealthy VolunteersHumansImmunoglobulin EInjections, SubcutaneousMaleMiddle AgedOmalizumabAntibodies, Monoclonal, HumanizedImmunoglobulin EOmalizumaballergic asthmafree IgE suppressionJYB1904pharmacodynamicspharmacokineticsphase Ia trial

Identifiers

PMID40504164
PMCPMC12160614

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.