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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

Suffering from primary or metastatic malignant tumors of the central nervous system;

Suffering from epilepsy, Parkinson'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.);

Trial design

Treatments tested in this trial

  • HSK21542
  • HSK21542
  • Dolasetron

Treatment groups

180 Participants
are divided into 3 treatment groups

Locations

This trial has no locations