Evidence map›Paper›PMID 38545854›Full record

Trial reportClinical and translational science2024

Safety, pharmacokinetics, and pharmacodynamics of anti-IL-4Rα antibody SHR-1819 in healthy subjects: A randomized, controlled phase I study.

Na Li, Sepehr Shakib, Weilin Qian, Xiaoyan Yao, Puyuan Li, Tsz Keung Nip, Xiaoyan Bai, Kai Shen

Abstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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

8 authors.

Na LiJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0001-9511-2384
Sepehr ShakibCMAX Clinical Research, Adelaide, South Australia, Australia.ORCID 0000-0002-7199-5733
Weilin QianJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0005-9851-6869
Xiaoyan YaoJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0008-8278-6241
Puyuan LiJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0006-3610-2617
Tsz Keung NipJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0001-6052-5111
Xiaoyan BaiJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0008-5358-0594
Kai ShenJiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.ORCID 0009-0009-0439-635X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

SHR-1819 is a novel anti-IL-4Rα monoclonal antibody currently under clinical development for use in patients with type 2 inflammatory diseases. In this randomized, double-blind, placebo-controlled, single-dose escalation phase I trial, we evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-1819 in healthy subjects. Subjects received a single subcutaneous injection of SHR-1819 or placebo, with dose escalation starting at 60 mg and subsequently increasing to 120, 240, 360, and 720 mg. A total of 42 eligible subjects were randomized, and 33 received SHR-1819 (1 subject in the 60 mg cohort and 8 subjects each in the 120, 240, 360 , and 720 mg cohorts) and 9 received placebo. SHR-1819 was well-tolerated, with the majority of adverse events being mild in severity. The exposure of SHR-1819 increased in a manner greater than proportionally with a dose range of 120 to 720 mg. The median T

Indexed as

Healthy VolunteersArea Under CurveBiomarkersDose-Response Relationship, DrugDouble-Blind MethodHumansInjections, SubcutaneousMetabolic Clearance RateBiomarkers

Identifiers

PMID38545854
PMCPMC10974694

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.