Evidence map›Paper›PMID 39680101›Full record

Trial reportNaunyn-Schmiedeberg's archives of pharmacology2025

The pharmacokinetics, pharmacodynamics and tolerability of SHR6508 in chinese healthy subjects: a randomized, placebo-controlled, double-blind, single-dose and dose-escalation phase I trial.

Sheng-Ting Zhang, Hong-Yi Tan, Shuang Yang, Xiao-Yan Yang, Chang Cui, Jie Huang, Guo-Ping Yang

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 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. Article
  2. 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

7 authors.

Sheng-Ting Zhang *Xiangya School of Pharmacy, Central South University, Changsha, 410013, Hunan, China.
Hong-Yi Tan *Center of Clinical Pharmacology, The Third, Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China.
Shuang YangCenter of Clinical Pharmacology, The Third, Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China.
Xiao-Yan YangCenter of Clinical Pharmacology, The Third, Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China.
Chang CuiCenter of Clinical Pharmacology, The Third, Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China.
Jie HuangCenter of Clinical Pharmacology, The Third, Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China. cellahuang1988@163.com.
Guo-Ping YangXiangya School of Pharmacy, Central South University, Changsha, 410013, Hunan, China. ygp9880@126.com.

Funding

Hunan Provincial Natural Science Foundation of China No. 2023JJ60513
6 · The paper itself

Abstract

This study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of SHR6508 injection, a new calcimimetic agent, in healthy Chinese subjects following single dose. This study utilized a placebo-controlled, single-dose, and dose-escalation design with four dose groups (0.5 mg, 2.5 mg, 5 mg, 10 mg). The trial started with a low dose and continuing to the next dose after completion of the out-of-group safety assessment of the previous dose group. Blood samples were collected at 15 time points to measure pharmacokinetic and pharmacodynamic parameters. Safety was assessed by therapeutic emergency adverse events (TEAEs), clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination. Of the 22 subjects who completed this study, 16 received SHR6508 Injection and 6 received placebo. In the 0.5-5 mg group, t

Indexed as

Receptors, Calcium-SensingAdultCalciumChinaDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHumansHyperparathyroidism, SecondaryMaleMiddle AgedYoung AdultCalciumReceptors, Calcium-SensingCalcimimetic agentsChronic kidney diseaseSafetySecondary hyperparathyroidism

Identifiers

PMID39680101
PMCPMC12125103

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.