NCT06506175
Not yet recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- HRS9531 tablets
- Conditions
- Overweight or Obese, Type 2 Diabetes
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- AUCtau
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- •Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body weight ≥50.0 kg, body mass index (BMI) of 24.0-35.0 kg/m\^2 (both inclusive) at screening.
- •Weight change does not exceed 5 kg within 3 months before screening.
- •Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG).
Exclusion Criteria
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •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.
- •Abnormal and clinically significant blood pressure at screening.
- •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.
- •Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
- •Presence of any clinically significant results in examination at screening visit.
- •Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
- •Presence of - clinically significant ECG results.
- •Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
- •Addiction to tobacco and alcohol.
Arms & Interventions
Treatment group A：Different fasting time、dosing conditions and timing
Intervention: HRS9531 tablets
Treatment group B：Different fasting time、dosing conditions and timing
Intervention: HRS9531 tablets
Treatment group C：Different fasting time、dosing conditions and timing
Intervention: HRS9531 tablets
Treatment group D：Different fasting time、dosing conditions and timing
Intervention: HRS9531 tablets
Treatment group E：Different fasting time、dosing conditions and timing
Intervention: HRS9531 tablets
Treatment group F：Different fasting time、dosing conditions and timing
Intervention: HRS9531 tablets
Treatment group G：Fed conditions
Intervention: HRS9531 tablets
Treatment group H：Fasting conditions
Intervention: HRS9531 tablets
Outcomes
Primary Outcomes
AUCtau
Time Frame: 0-24hrs after the 10th dosing
Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing
Secondary Outcomes
- Tmax(First dose at day 1 and post-dose at day 10)
- Cmax(First dose at day 1 and post-dose at day 10)
- Incidence and severity of adverse events(Screening period up to Day 45)
- t1/2(First dose at day 1 and post-dose at day 10)
- Anti-HRS9531 antibody(Before First dose at day 1 to Day 45)
Study Sites (1)
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