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Completed

NCT Number: NCT06157450

Pharmacokinetics of ZSP1273 in Elder Participants

The purpose of this study is to assess the safety, tolerability and PK of ZSP1273 in elder Participants

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sir Run Run Hospital

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

ZSP1273

Drug

Participants receive ZSP1273 orally.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Day 1 to Day 5

    The Cmax of a single dose of ZSP1273 in elder participants and young participates will be evaluated and compared.

  2. Area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: Day 1 to Day 5

    The AUCinf of a single dose of ZSP1273 in elder participants and young participates will be evaluated and compared.

  3. Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)

    Time frame: Day 1 to Day 5

    The AUClast of a single dose of ZSP1273 in elder participants and young participates will be evaluated and compared.

Secondary outcomes

  1. Number of participants with drug-related adverse events as assessed by CTCAE v5.0

    Time frame: Day 1 to Day 5

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate Pharmacokinetics, Safety and Tolerability of ZSP1273 in Elder Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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