Not Yet RecruitingPhase 2

Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting

180 participantsStarted 2024-09-16

Plain-language summary

This is a multicenter, randomized, double-blind, active-controlled dose-finding study. About 180 subjects who receive a high emetic chemotherapy are planned to be enrolled and randomized into three groups by a ratio of 1:1:1.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓.18 years of age or older, of either gender;
✓. Absolute neutrophil count ≥ 1.5 × 109/L, white blood cell count ≥ 3.0 × 109/L;
✓. Platelet count ≥ 75 × 109/L;
✓. Hemoglobin ≥ 70 g/L;
✓. Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
✓. Alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);
✓. Serum total bilirubin ≤ 2 × ULN (≤ 3 × ULN for patients with hepatocellular carcinoma or liver metastasis);
✓. Creatinine ≤ 2 × ULN;

Exclusion criteria

✕. History or evidence of any of the following diseases prior to screening:
✕. Suffering from primary or metastatic malignant tumors of the central nervous system;
✕. Suffering from epilepsy, Parkinson\&amp;amp;amp;amp;#39;s disease, or other central nervous system disorders that cause nausea and vomiting;
✕. Suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers;
✕. Suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);
✕. History of obvious and chronic dizziness;
✕. QT interval\&amp;amp;amp;amp;gt;450 ms during screening or taking concomitant medications due to prolonged QT interval or has risk factors for QT interval prolongation or correspon;
✕. Allergies or contraindications to the study drugs or other drugs specified in the protocol (including chemotherapy drugs, investigational drugs and mimetics, dorasetron, aripipitan, dexamethasone, etc.) ;

What they're measuring

Acute Complete response

Timeframe: 0 to 24 hours

Trial details

NCT IDNCT06593782

SponsorFirst Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-11

Contact for this trial

Shen Xian

13968888872 13968888872@163.com

View on ClinicalTrials.gov More Nausea and Vomiting, Chemotherapy-Induced trials