Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Overweight or Obese, Type 2 Diabetes
• Interventions: Drug: HRS9531 tablets

• Registration Number: NCT06506175
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Study Start: 2024-08-05
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 144

Inclusion Criteria

1. Ability to understand the trial procedures, be able and willing to provide a written informed consent.
2. Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
3. Body weight ≥50.0 kg, body mass index (BMI) of 24.0-35.0 kg/m^2 (both inclusive) at screening.
4. Weight change does not exceed 5 kg within 3 months before screening.
5. Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).

Exclusion Criteria

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
3. Abnormal and clinically significant blood pressure at screening.
4. History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.
5. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
6. Presence of any clinically significant results in examination at screening visit.
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
8. Presence of - clinically significant ECG results.
9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
10. Addiction to tobacco and alcohol.
11. Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period.
12. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group B：Different fasting time、dosing conditions and timing	HRS9531 tablets	-
Treatment group E：Different fasting time、dosing conditions and timing	HRS9531 tablets	-
Treatment group F：Different fasting time、dosing conditions and timing	HRS9531 tablets	-
Treatment group G：Fed conditions	HRS9531 tablets	-
Treatment group A：Different fasting time、dosing conditions and timing	HRS9531 tablets	-
Treatment group C：Different fasting time、dosing conditions and timing	HRS9531 tablets	-
Treatment group D：Different fasting time、dosing conditions and timing	HRS9531 tablets	-
Treatment group H：Fasting conditions	HRS9531 tablets	-

Primary Outcome Measures

Name	Time	Method
AUCtau	0-24hrs after the 10th dosing	Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing

Secondary Outcome Measures

Name	Time	Method
t1/2	First dose at day 1 and post-dose at day 10	Terminal half-life
Tmax	First dose at day 1 and post-dose at day 10	Time to maximum plasma concentration
Cmax	First dose at day 1 and post-dose at day 10	The maximum plasma concentration
Incidence and severity of adverse events	Screening period up to Day 45
Anti-HRS9531 antibody	Before First dose at day 1 to Day 45

Trial Locations

Locations (1)

The affiliated hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China