A Trial of HRS-7450 in Chinese Healthy Volunteers

Randomized, Double-blind, Placebo-controlled, Single-dose Ascending Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7450 in Healthy Subjects.

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending doses of HRS-7450 given to healthy subjects, compared to placebo..

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Stroke
• Intervention / Treatment: Drug: HRS-7450 ；Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuanyuan Huang; Phone Number: +0518-82342973; Email: yuanyuan.huang@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male and female subjects between 18 and 45 years of age (inclusive) at the screening visit
2. Female weighed ≥ 45 kg, male weighed ≥ 50 kg, and all weighed ≤ was 90 kg, and a BMI between 18-28 kg/m²(inclusive)
3. Subjects with fertility promised to have no fertility, sperm or egg donation plan and voluntarily take efficient contraceptive measures ( including partners ) within two weeks before screening and 6 months after the last administration
4. Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial

Exclusion Criteria:

1. Subjects with a history of drug allergy, or a history of allergy ( asthma, urticaria, eczema, etc. ), or allergic constitution ( such as allergies to two or more drugs, food, and pollen ) or intolerance to any ingredients of the study drug
2. Subjects with heart, respiration, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, nervous system disease or mental illness, metabolic dysfunction prior to screening or administration
3. The results of physical examination, vital sign examination, laboratory examination, etc. during the screening are deemed clinically significant
4. Subjects with risk factors for torsades de pointes ventricular tachycardia, or had a family history of short QT syndrome, long QT syndrome, unexplained sudden death in youth ( ≤ 40 years old ), drowning or sudden infant death syndrome in first-degree relatives ( i.e., biological parents, siblings or children )
5. Subjects with hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia are deemed clinically significant
6. ECG examination is clinical significant, such as QTcF > 470ms
7. Subjects with gastrointestinal, urinary and other bleeding tendencies or other high-risk bleeding tendencies within 3 weeks before screening; or those who have arterial puncture within the past 1 week that does not easily compress the hemostatic site were included
8. ALT, AST, total bilirubin, direct bilirubin and indirect bilirubin exceeded the upper limit of normal value during screening visit
9. Positive test for human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or syphilis at the Screening Visit.
10. Subjects who underwent surgery within 3 months before screening or schedule to have surgery during the trial, or those who have previously had surgery that may affect the PK profile or safety evaluation significantly of the study drug
11. Subjects who received any IMP within 3 months before the screening visit or planned to participate in other clinical trials during the trial
12. Received any drug that inhibits or induces liver metabolism of the drug within 1 month prior to screening visit
13. Received any prescription drugs (including vaccines) or non-prescription medications, and herbal supplements within 2 weeks prior to screening visit
14. Blood donation or blood loss≥200 mL within 3 month before screening, or schedule to donate blood during the trial or within 1 month after the end of the trial.
15. Had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (averaging more than 8 cups per day of 200 ml each) in the 2 weeks prior to screening visit
16. History of alcohol abuse [more than 14 units of alcohol intake in one week (1 unit of alcohol equivalent to 285 mL of beer, 25 mL of spirits, or 100ml of wine), more than twice a week]
17. More than 10 cigarettes( or equivalent tobacco)per day in the 3 months prior to screening or unable to quit smoking during the trial period
18. Positive urine drug test at the Screening Visit History of drug abuse within the past 5 years
19. Pregnant or lactating women, or pregnancy test positive
20. Can not tolerate venipuncture or have a history of needle sickness and blood
21. Subjects with history of phlebitis
22. In the opinion of the Investigator, subjects should be excluded in this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohor 1: HRS-7450 dose 1 or Placebo;	Drug: HRS-7450 ；Placebo; HRS-7450 or Placebo
Experimental: Cohor 1: HRS-7450 dose 2 or Placebo;	Drug: HRS-7450 ；Placebo; HRS-7450 or Placebo
Experimental: Cohor 1: HRS-7450 dose 3 or Placebo;	Drug: HRS-7450 ；Placebo; HRS-7450 or Placebo
Experimental: Cohor 1: HRS-7450 dose 4 or Placebo;	Drug: HRS-7450 ；Placebo; HRS-7450 or Placebo
Experimental: Cohor 1: HRS-7450 dose 5 or Placebo;	Drug: HRS-7450 ；Placebo; HRS-7450 or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)		8 +/- 1 days
Physical examination	Incidence of clinically significant physical examination findings	2 days
Vital signs	Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature	2 days
12-lead electrocardiogram (ECG)	Incidence of clinically significant findings in heart rate, PR interval, RR and QRS interval	24 hours

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HRS-7450-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No