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NOT YET RECRUITING
NCT06593782
PHASE2

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

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Active-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2024-09-16

Completion Date

2025-09-01

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

HSK21542

1. HSK21542 injection was administered day 1; 2. Placebo to match Dorasetron was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;

DRUG

HSK21542

1. HSK21542 injection was administered day 1; 2. Placebo to match Dorasetron was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;

DRUG

Dolasetron

1. Placebo to match HSK21542 injection was administered day 1; 2. Dorasetron injection was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;