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A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HRS-9190 in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HRS-9190 in Healthy Adults

NCT07142850•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is divided into two parts. The first part adopts a single-center, randomized, single-blind, placebo-controlled dose escalation trial design to investigate the safety, tolerability, pharmacokinetics (PK), and effects on the QTc interval in healthy subjects after a single administration of HRS-9190 for injection at doses of 3 times or 6 times the ED95. The second part uses a single-center, open-label trial design to examine the safety, tolerability, PK, pharmacodynamics (PD), and reversal effect of neostigmine (in combination with atropine) after intravenous bolus injection and continuous intravenous infusion of the loading dose (2 times the ED95) of HRS-9190 under different anesthesia regimens.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Before the trial, the subjects have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial. They can understand the procedures and methods of this study, are willing to strictly abide by the requirements of the entire clinical study, and voluntarily sign the informed consent form.
•2. Aged between 18 and 45 years (inclusive) at the time of signing the informed consent form, with both males and females eligible;
•3. ASA physical status classification of Class I;
•4. At the screening period, male subjects must weigh ≥50 kg, female subjects must weigh ≥45 kg, and the body mass index (BMI = weight (kg)/height² (m²)) is between 19 and 28 kg/m² (inclusive);
•5. Female subjects of childbearing potential must agree to use highly effective contraception and avoid donating eggs from the time of signing the informed consent form until 3 months after the last dose of the investigational product. Serum pregnancy tests at the screening and baseline periods must be negative, and they must not be breastfeeding. Male subjects whose partners are females of childbearing potential must agree to use highly effective contraception and avoid donating sperm from the time of signing the informed consent form until 3 months after the last dose of the investigational product.

Exclusion Criteria

•1. Subjects with a history or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic abnormalities, who are deemed unsuitable for enrollment by the investigator;
•2. Subjects with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism) or a history of poliomyelitis;
•3. Subjects with a history of anesthetic complications (such as a history of malignant hyperthermia or a family history of malignant hyperthermia, or those susceptible to malignant hyperthermia (patients with congenital diseases such as idiopathic scoliosis, strabismus, ptosis, umbilical hernia, inguinal hernia, etc.));
•4. Subjects with a history of asthma, a history of airway diseases requiring treatment or anatomical airway abnormalities, or signs of airway abnormalities assessed during screening airway examination that may affect laryngoscope insertion or tracheal intubation;
•5. During the screening or baseline period: subjects with clinically significant abnormal physical examination results as judged by the study doctor; subjects with clinically significant abnormal electrocardiograms or those with persistently/repeatedly QTcF \> 450 ms in males and \> 470 ms in females; subjects with hyperkalemia or hypokalemia that are judged by the investigator to be abnormal and clinically significant;
•6. Subjects with a known history of allergy to the study drug or its excipients, or those with an allergic constitution (allergic to 2 or more drugs and foods);
•7. Subjects who have undergone major surgery within 6 months before screening, or have a history of surgery that may significantly affect the pharmacokinetic characteristics or safety evaluation of the study drug (such as liver or kidney transplantation), or plan to undergo surgery during the trial;
•8. Subjects with contraindications to the following drugs (midazolam, propofol, sufentanil, neostigmine, atropine, and sevoflurane): acute angle-closure glaucoma, allergy to eggs, egg products, soybeans or soybean products, epilepsy, angina pectoris, ventricular tachycardia, mechanical intestinal obstruction, urinary tract obstruction, arrhythmia, sinus bradycardia, hypotension, increased vagal tone, benign prostatic hyperplasia, high fever, moderate/moderate hepatic insufficiency, and the following symptoms related to halogenated anesthetics (liver dysfunction, jaundice, fever, or eosinophilia), etc.;
•9. Subjects who have used any drugs that inhibit or induce hepatic drug metabolism (such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 1 month before drug administration;
•10. Subjects who have taken antihistamines or antidepressants within 3 months before screening;
+14 more criteria

Locations (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Key Dates

Start Date

August 26, 2025

Primary Completion Date

October 31, 2025

Completion Date

October 31, 2025

Last Updated

November 28, 2025

Enrollment

ACTUAL participants

Conditions

Skeletal Muscle Relaxation

Interventions

HRS-9190

DRUG