Cerebral StrokePhase 1NCT06087094
A Trial of HRS-7450 in Chinese Healthy Volunteers
A Phase 1 study of Cerebral Stroke, run by Fujian Shengdi Pharmaceutical Co., Ltd..
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Stroke
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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]
- 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
- Positive urine drug test at the Screening Visit History of drug abuse within the past 5 years
- Pregnant or lactating women, or pregnancy test positive
- Can not tolerate venipuncture or have a history of needle sickness and blood
- Subjects with history of phlebitis
- In the opinion of the Investigator, subjects should be excluded in this trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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..
- Conditions
- Cerebral Stroke
- Being tested
- HRS-7450 ；Placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7450 ；PlaceboDrug
HRS-7450 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohor 1: HRS-7450 dose 1 or Placebo; | Experimental | Not described Receives: Drug: HRS-7450 ；Placebo |
| Cohor 1: HRS-7450 dose 2 or Placebo; | Experimental | Not described Receives: Drug: HRS-7450 ；Placebo |
| Cohor 1: HRS-7450 dose 3 or Placebo; | Experimental | Not described Receives: Drug: HRS-7450 ；Placebo |
| Cohor 1: HRS-7450 dose 4 or Placebo; | Experimental | Not described Receives: Drug: HRS-7450 ；Placebo |
| Cohor 1: HRS-7450 dose 5 or Placebo; | Experimental | Not described Receives: Drug: HRS-7450 ；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Measured: 8 +/- 1 days
Physical examination
Incidence of clinically significant physical examination findings
Measured: 2 days
Vital signs
Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
Measured: 2 days
12-lead electrocardiogram (ECG)
Incidence of clinically significant findings in heart rate, PR interval, RR and QRS interval
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087094
- Sponsor's protocol ID
- HRS-7450-101
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Single-dose Ascending Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7450 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06087094
- Acronym / sponsor ID
- HRS-7450-101
- Conditions
- Cerebral Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-7450 ；PlaceboHRS-7450 or Placebo | Drug | 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; |
Primary outcome
Adverse Events (AEs)
Time frame: 8 +/- 1 days
Physical examination
Time frame: 2 days
Incidence of clinically significant physical examination findings
Vital signs
Time frame: 2 days
Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
12-lead electrocardiogram (ECG)
Time frame: 24 hours
Incidence of clinically significant findings in heart rate, PR interval, RR and QRS interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Cerebral Stroke, run by Fujian Shengdi Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Huang (+0518-82342973, yuanyuan.huang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: 8 +/- 1 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.