Status:
COMPLETED
Pharmacokinetics of ZSP1273 in Elder Participants
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
Elder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability and PK of ZSP1273 in elder Participants
Eligibility Criteria
Inclusion
- Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI\<28 kg/m2,BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃
- Young Participants Only:
- Participants must be ≥18 to ≤45 years old
- Elder Participants Only:
- Participants must be ≥65 years old
Exclusion
- Participants with an allergic disposition (multiple drug and food allergies)
- Participants who donated blood or bleeding profusely (\> 400 mL) in the 3 months.
- Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection), within 2 weeks before screening;
- Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles
- Young Participants Only:
- Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;
- Physical examination, vital signs, laboratory tests (blood routine +CRP, urine routine + urine sediment, blood biochemistry, coagulation function, infectious disease test, glycosylated hemoglobin test), 12-lead electrocardiogram, chest CT, abdominal color Doppler ultrasound and other examinations have clinical significance
- Elder Participants Only:
- Participants had a history of or evidence of cardiovascular disease before screening: uncontrolled hypertension, orthostatic hypotension, severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months before screening, or history of tachycardia/bradycardia requiring medical treatment, and degree II-III atrioventricular block.
- Participants who had other serious organ-systemic serious diseases at screening, including but not limited to respiratory, neurologic, hematologic, endocrine, oncologic, immunologic, psychiatric, or cardio-cerebrovascular diseases, and was judged by the investigator to be ineligible for participation in the trial
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06157450
Start Date
October 11 2023
End Date
November 17 2023
Last Update
December 5 2023
Active Locations (1)
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1
Sir Run Run Hospital
Nanjing, Jiangsu, China