Clinical trial NCT06506175: Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects
Official title: A Phase I Clinical Trial to Evaluate the Effects of Different Dosing Conditions, Timing and Food on the Pharmacokinetics of HRS9531 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Overweight or Obese, Type 2 Diabetes
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparisons between arms with different dosing conditions, timing and food for oral HRS9531 tablets
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: AUCtau
timeFrame: 0-24hrs after the 10th dosing
Secondary outcomes:
measure: Tmax
timeFrame: First dose at day 1 and post-dose at day 10
measure: Cmax
timeFrame: First dose at day 1 and post-dose at day 10
measure: t1/2
timeFrame: First dose at day 1 and post-dose at day 10
measure: Incidence and severity of adverse events
timeFrame: Screening period up to Day 45
measure: Anti-HRS9531 antibody
timeFrame: Before First dose at day 1 to Day 45
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The affiliated hospital of Qingdao University
state: Shandong
Study officials:
References: