Clinical Trials/NCT06441227

NCT06441227

Completed

Phase 1

Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Food Effects of Single and Multiple Oral HRS-5346 Tablets in Healthy Subjects

Shandong Suncadia Medicine Co., Ltd.1 site in 1 country71 target enrollmentJune 13, 2024

ConditionsLipoprotein Disorder Disease

InterventionsHRS-5346 tablets placebo

DrugsHRS-5346 tablets placebo

Overview

Phase: Phase 1
Intervention: HRS-5346 tablets
Conditions: Lipoprotein Disorder Disease
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 71
Locations: 1
Primary Endpoint: Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.

Registry

clinicaltrials.gov

Start Date

June 13, 2024

End Date

January 9, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the specific process of the test, voluntarily participate in this test, and sign the informed consent in writing.
•Age ≥ 18 and ≤ 55 years old on the day of signing the informed consent (including boundary value).
•Male subjects weigh ≥ 50 kg, female subjects weigh ≥ 45kg, and BMI is in the range of 19\~30 kg/m2 (including boundary values).
•Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from the time of signing the informed consent form to the last time the drug is given; the female subject's blood pregnancy test must be negative and non-lactation.
•Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance.

Exclusion Criteria

•Those who suffer from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease or medical history that can interfere with the test results or any significant laboratory abnormality that is judged by researchers to be of clinical significance.
•Previous history of malignant tumors.
•Those who have taken any prescription drugs, over-the-counter drugs and Chinese herbs within 14 days before taking the study drug, or within 5 half-life of the drug at the time of screening; those who plan to take non-study drugs during the trial period.
•Those who have participated in the clinical trial of any drug or medical device within 3 months before screening, or have not been within 5 half-life of the drug before screening (when both standards are met, the standard shall be based on the long-term standard).
•Subjects received siRNA in the past 12 months, or antisense oligonucleotide drugs in the past six months.
•The abnormal upper limit of hypersensitive C-reactive protein during the screening period is \>1.5 times the normal upper limit, or the normal upper limit of prothrombin time/international standard ratio (PT/INR), activated partial thrombin time (aPTT) \> 1.25 times normal upper limit.
•Screening for infectious diseases during the screening period (including hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis spirochete antibody).
•12-lead electrocardiogram abnormal and clinical significance, or electrocardiogram QT interval (QTcF) male \> 450 ms, female \> 470 ms.
•The total amount of blood donated or blood loss ≥ 200 mL within 1 month before administration, or the total amount of blood donation or blood loss ≥ 400 mL within 3 months before administration, or received blood transfusion within 8 weeks.
•Those who have a serious infection, serious trauma or major surgery within 3 months before administration; those who plan to undergo surgery within two weeks during and after the end of the trial.

Arms & Interventions

Part 1

HRS-5346 tablets or placebo single dose

Intervention: HRS-5346 tablets

Part 1

HRS-5346 tablets or placebo single dose

Intervention: placebo

Part 2

HRS-5346 tablets or placebo single dose with food effects

Intervention: HRS-5346 tablets

Part 2

HRS-5346 tablets or placebo single dose with food effects

Intervention: placebo

Part 3

HRS-5346 tablets or placebo multiple doses

Intervention: HRS-5346 tablets

Part 3

HRS-5346 tablets or placebo multiple doses

Intervention: placebo

Outcomes

Primary Outcomes

Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets

Time Frame: About three months from the first medication to the evaluation

Secondary Outcomes

Evaluation of Tmax of HRS-5346 in plasma(About three months after the first dose)
Evaluation of Cmax of HRS-5346 in plasma(About three months after the first dose)
Evaluation of t1/2 of HRS-5346 in plasma(About three months after the first dose)
Evaluation of CL/F of HRS-5346 in plasma(About three months after the first dose)
Evaluation of AUC0-t of HRS-5346 in plasma and urine(About three months after the first dose)
Evaluation of Vz/F of HRS-5346 in plasma(About three months after the first dose)
Evaluation of AUC0-inf of HRS-5346 in plasma(About three months after the first dose)
Evaluation of Ae of HRS-5346 in urine(About three months after the first dose)
Evaluation of fe of HRS-5346 in urine(About three months after the first dose)
Evaluation of CLR of HRS-5346 in urine(About three months after the first dose)