Evidence map›Paper›PMID 40601394›Full record

Trial reportClinical and translational science2025

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of HSK39297 in Chinese Healthy Subjects: A Phase 1 Clinical Trial.

Yuyang Dai, Feng Wu, Siyang Ni, Xiaojun Hu, Ying Han, Ying Jiao, Huan Lu, Yilin Liu, Lingling Wang, Yunfei Lin and 5 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

15 authors.

Yuyang DaiNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-1679-1508
Feng WuNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-1447-8895
Siyang NiNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-3746-7184
Xiaojun HuNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0009-0000-4921-469X
Ying HanNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0009-0005-4235-0740
Ying JiaoNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0009-0007-2488-8592
Huan LuNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0009-0003-8185-746X
Yilin LiuNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0009-0000-3972-4135
Lingling WangHaisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.ORCID 0009-0002-3434-5501
Yunfei LinHaisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.ORCID 0009-0001-8707-5640
Meixia ChenHaisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.ORCID 0000-0002-7328-058X
Chao WangHaisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.ORCID 0009-0006-0402-1695
Qinghe WuHaisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.ORCID 0009-0002-8521-8043
Fangqiong LiHaisco Pharmaceutical Group Co., Ltd., Chengdu, Sichuan Province, China.ORCID 0009-0001-3641-3304
Laichun LuNational Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-4439-9108

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

HSK39297 is a novel complement factor B inhibitor, and this phase 1 trial was designed to assess its pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability in healthy Chinese subjects. This study included 46 subjects in the single ascending dose (SAD) part (50-600 mg) and 50 subjects in the multiple ascending dose (MAD) part (50-125 mg BID and 200-300 mg QD). Among them, a food effect study was conducted in the SAD 200 mg group. Adverse events (AEs) reported after the initial dose of the study drug were considered treatment-emergent AEs (TEAEs). Blood samples were collected to measure plasma concentrations of HSK39297 at predefined time points and analyzed at a centralized laboratory. In addition, PD analysis was conducted by measuring complement alternative pathway (AP) activity and Bb concentrations. According to the results, we found single and multiple doses of HSK39297 were safe and well tolerated in all subjects. Within SAD of 50-600 mg dose range, the C

Indexed as

Complement Inactivating AgentsAdministration, OralAdultArea Under CurveAsian PeopleChinaDose-Response Relationship, DrugFemaleFood-Drug InteractionsHealthy VolunteersHumansMaleMiddle AgedYoung AdultComplement Inactivating Agentscomplement factor B inhibitorcomplement systemglomerular diseasespharmacodynamicspharmacokineticssafety

Identifiers

PMID40601394
PMCPMC12219017

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.