Pharmacokinetics of ZSP1273 in Elder Participants

NCT06157450 | Completed Phase 1

• 1 other identifier: ZSP1273-23-15
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Elder

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

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

  Day 1 to Day 5

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

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

  Day 1 to Day 5

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

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

  Day 1 to Day 5

Secondary Outcomes (1)

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

  Day 1 to Day 5

Study Arms (2)

Experimental: young participates

EXPERIMENTAL

16 young participants(between 18\~45 years old) will be given 600mg of ZSP1273.

Drug: ZSP1273

Experimental:elder participates

EXPERIMENTAL

16 elder participants(Age≥65 years old) will be given 600mg of ZSP1273.

Drug: ZSP1273

Interventions

ZSP1273 DRUG

Participants receive ZSP1273 orally.

Experimental: young participates; Experimental:elder participates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Sir Run Run Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

ZSP1273

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 5, 2023
• Study Start: October 11, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 17, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

CN (1)