Evidence map›Paper›PMID 35404074›Full record

Trial reportAntimicrobial agents and chemotherapy2022

Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Expression Inhibitor GST-HG131 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial.

Xiaojiao Li, Yusi Liu, Hanxin Yao, Meng Wang, Lei Gao, Jinfeng Lou, John Mao, Wenqiang Wu, Yixin Zhou, Yanan Tang and 6 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 21% of its field
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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. [Research progress on new drugs for the treatment of chronic hepatitis B virus infection].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
  5. Article
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

16 authors at 2 institutions in 1 country.

Xiaojiao LiPhase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.
Yusi LiuPhase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.
Hanxin YaoDepartment of Clinical Laboratory, First Hospital, Jilin University, Changchun, China.
Meng WangPhase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.
Lei GaoPhase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.
Jinfeng LouPhase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.
John MaoFujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.
Wenqiang WuFujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.
Yixin ZhouFujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.
Yanan TangFujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.
Wenhao YanFujian Cosunter Pharmaceutical Co., Ltd, Fujian, China.
Yanbin HuWuXi AppTec, Wuhan, China.
Charles DingWuXi AppTec, Shanghai, China.
Shuhui ChenWuXi AppTec, Shanghai, China.
Junqi NiuDepartment of Hepatology, First Hospital, Jilin University, Changchun, China.
Yanhua DingPhase I Clinical Trial Unit, First Hospital, Jilin University, Changchun, China.ORCID 0000-0003-2320-4404
Jilin University · CNWuXi AppTec (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

GST-HG131, a novel dihydroquinolizinone (DHQ) compound, has been shown to reduce circulating levels of HBsAg in animals. This first-in-human trial evaluated the safety, tolerability, and pharmacokinetic profile of GST-HG131 in healthy Chinese subjects. This was a double-blind, randomized, placebo-controlled phase Ia clinical trial that was conducted in two parts. Part A was a single-ascending-dose (SAD; GST-HG131 10 30, 60, 100, 150, 200, 250 or 300 mg or placebo) study, which also assessed the food effect of GST-HG131 100 mg. Part B was a multiple-ascending-dose (MAD; GST-HG131 30, 60 or 100 mg or placebo BID) study. Tolerability assessments included adverse events, vital signs, 12-lead electrocardiogram, physical examination, and clinical laboratory tests. PK analyses were conducted in blood, urine, and fecal samples. Single doses of GST-HG131 ≤ 300 mg and multiple doses of GST-HG131 ≤ 60 mg were generally safe and well tolerated; however, multiple dosing was stopped at GST-HG131 100 mg, as pre-defined stopping rules specified in the protocol were met (Grade II drug related AEs of nausea and dizziness in >50% of subjects). In the SAD study, median t

Indexed as

Hepatitis B virusArea Under CurveChinaDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansfood effectGST-HG131hepatitis B virus expression inhibitorpharmacokineticssafety

Identifiers

PMID35404074
PMCPMC9112976
OpenAlexW4223474800

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.