Pharmacokinetics of ZSP1273 in Elder Participants

• Sponsor: Guangdong Raynovent Biotech Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06157450
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 26.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Elder	Drug: ZSP1273	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate Pharmacokinetics, Safety and Tolerability of ZSP1273 in Elder Participants
• Actual Study Start Date: Oct 11, 2023
• Actual Primary Completion Date: Nov 1, 2023
• Actual Study Completion Date: Nov 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: young participates 16 young participants(between 18~45 years old) will be given 600mg of ZSP1273.	Drug: ZSP1273; Participants receive ZSP1273 orally.
Experimental: Experimental:elder participates 16 elder participants(Age≥65 years old) will be given 600mg of ZSP1273.	Drug: ZSP1273; Participants receive ZSP1273 orally.

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [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) [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) [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 Outcome Measures

1. Number of participants with drug-related adverse events as assessed by CTCAE v5.0 [Day 1 to Day 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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.

2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.

3. 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).

4. Heart rate between 50-100 beats/min, Body temperature between 35.7-37.5℃

Young Participants Only:

1. Participants must be ≥18 to ≤45 years old

Elder Participants Only:

1. Participants must be ≥65 years old

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies)

2. Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.

3. Participants with clinically significant disease, such as gastrointestinal disease, infection (e.g., respiratory or central nervous system infection), within 2 weeks before screening;

4. Participants who could not tolerate blood collection by venipuncture and/or had a history of dizzy with blood and needles

Young Participants Only:

1. Participants had taken or planned to take any prescription medication, over-the-counter medication, vitamin product, or herbal medicine within 2 weeks before screening;

2. 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:

1. 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.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sir Run Run Hospital	Nanjing	Jiangsu	China

Sponsors and Collaborators

• Guangdong Raynovent Biotech Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guangdong Raynovent Biotech Co., Ltd
• ClinicalTrials.gov Identifier: NCT06157450
• Other Study ID Numbers: ZSP1273-23-15
• First Posted: Dec 5, 2023
• Last Update Posted: Dec 5, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 5, 2023