A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3032 Following Single Intravenous Administration in Healthy Subjects

Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country6 target enrollmentNovember 29, 2023

ConditionsPrevention of Graft Rejection After Organ Transplantation

InterventionsSHR-3032 SHR-3032 Placebo

Overview

Phase: Phase 1
Intervention: SHR-3032
Conditions: Prevention of Graft Rejection After Organ Transplantation
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment: 6
Locations: 1
Primary Endpoint: Pharmacokinetic parameter of SHR-3032: AUC0-∞
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, double-blind, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3032 in healthy adults.

Registry

clinicaltrials.gov

Start Date

November 29, 2023

End Date

April 8, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The age when signing the informed consent form is between 18 and 55 years old (inclusive);
•Male weight ≥ 50 kg and female weight ≥ 45 kg, body mass index (BMI) is between 19.0 \~ 28.0 kg/m2 (inclusive) during the screening period;
•The subject has no plans to donate sperm or eggs from signing the informed consent form to 6 months following administration. Female subjects with reproductive potential must conduct a serum pregnancy test within 7 days before the first drug use, and the result is Negative. Fertile female subjects and male subjects whose partners are females of childbearing age must agree to comply with contraceptive requirements from signing the informed consent form to 6 months following administration;
•Female subjects: non-pregnant or non-lactating;
•The subject has a detailed understanding of the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the study, can understand the procedures and methods of this study, and is willing to strictly abide by the requirements of the entire clinical study and voluntarily signed the informed consent.

Exclusion Criteria

•Previously or currently suffering from clinical acute and chronic diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, who are judged by the researchers to be inappropriate for enrollment;
•During the screening period, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the upper limit of the normal range (ULN), or total bilirubin (TBIL) ≥ 1.5 times the ULN, or lymphocytes were lower than the lower limit of the normal range;
•The subjects' medical history, symptoms and examination results at the time of screening suggest that they have active tuberculosis or latent tuberculosis;
•Those who had chronic infection or recurrent infection and needed treatment within 12 months before screening;
•People with hereditary bleeding or coagulation disorders, or a history of non-traumatic bleeding (bleeding requiring treatment);
•Those who are at risk of thromboembolic events (such as thromboembolism in cardiovascular, cerebrovascular, peripheral blood vessels);
•Previous medical history of torsade de pointes, symptomatic ventricular arrhythmia, or personal or family history of short QT syndrome or long QT syndrome;
•Patients with abnormal and clinically significant hyperkalemia and hypokalemia judged by the investigator;
•People who are known to have a history of allergies to this product, its excipients, similar drugs, or allergic constitution (allergic to 2 or more drugs and food);
•Those who have undergone major surgery within 3 months before screening, or those who have previously received surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug, or those who plan to undergo surgery during the study period;

Arms & Interventions

Treatment group A

SHR-3032

Intervention: SHR-3032

Treatment group B

SHR-3032 Placebo

Intervention: SHR-3032 Placebo