A Trial of HRS-7450 in Chinese Healthy Volunteers

NCT06087094 | Unknown Phase 1

• 1 other identifier: HRS-7450-101
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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..

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (5)

Cohor 1: HRS-7450 dose 1 or Placebo;

EXPERIMENTAL

Drug: HRS-7450 ；Placebo

Cohor 1: HRS-7450 dose 2 or Placebo;

EXPERIMENTAL

Drug: HRS-7450 ；Placebo

Cohor 1: HRS-7450 dose 3 or Placebo;

EXPERIMENTAL

Drug: HRS-7450 ；Placebo

Cohor 1: HRS-7450 dose 4 or Placebo;

EXPERIMENTAL

Drug: HRS-7450 ；Placebo

Cohor 1: HRS-7450 dose 5 or Placebo;

EXPERIMENTAL

Drug: HRS-7450 ；Placebo

Interventions

HRS-7450 ；Placebo DRUG

HRS-7450 or Placebo

Cohor 1: HRS-7450 dose 1 or Placebo;; Cohor 1: HRS-7450 dose 2 or Placebo;; Cohor 1: HRS-7450 dose 3 or Placebo;; Cohor 1: HRS-7450 dose 4 or Placebo;; Cohor 1: HRS-7450 dose 5 or Placebo;

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects between 18 and 45 years of age (inclusive) at the screening visit
• Female weighed ≥ 45 kg, male weighed ≥ 50 kg, and all weighed ≤ was 90 kg, and a BMI between 18-28 kg/m²(inclusive)
• 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
• 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

You may not qualify if:

• 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
• 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
• The results of physical examination, vital sign examination, laboratory examination, etc. during the screening are deemed clinically significant
• 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 )
• Subjects with hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia are deemed clinically significant
• ECG examination is clinical significant, such as QTcF \> 470ms
• 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
• ALT, AST, total bilirubin, direct bilirubin and indirect bilirubin exceeded the upper limit of normal value during screening visit
• 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.
• 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
• Subjects who received any IMP within 3 months before the screening visit or planned to participate in other clinical trials during the trial
• Received any drug that inhibits or induces liver metabolism of the drug within 1 month prior to screening visit
• Received any prescription drugs (including vaccines) or non-prescription medications, and herbal supplements within 2 weeks prior to screening visit
• 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.
• 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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuanyuan Huang

CONTACT

+0518-82342973; yuanyuan.huang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 17, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10