Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects

NCT06506175 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS9531-T-102
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight or Obese, Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• AUCtau

  Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing

  0-24hrs after the 10th dosing

Secondary Outcomes (5)

• Tmax

  First dose at day 1 and post-dose at day 10

• Cmax

  First dose at day 1 and post-dose at day 10

• t1/2

  First dose at day 1 and post-dose at day 10

• Incidence and severity of adverse events

  Screening period up to Day 45

• Anti-HRS9531 antibody

  Before First dose at day 1 to Day 45

Study Arms (8)

Treatment group A：Different fasting time、dosing conditions and timing

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group B：Different fasting time、dosing conditions and timing

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group C：Different fasting time、dosing conditions and timing

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group D：Different fasting time、dosing conditions and timing

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group E：Different fasting time、dosing conditions and timing

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group F：Different fasting time、dosing conditions and timing

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group G：Fed conditions

EXPERIMENTAL

Drug: HRS9531 tablets

Treatment group H：Fasting conditions

EXPERIMENTAL

Drug: HRS9531 tablets

Interventions

HRS9531 tablets DRUG

HRS9531 tablets

Treatment group A：Different fasting time、dosing conditions and timing; Treatment group B：Different fasting time、dosing conditions and timing; Treatment group C：Different fasting time、dosing conditions and timing; Treatment group D：Different fasting time、dosing conditions and timing; Treatment group E：Different fasting time、dosing conditions and timing; Treatment group F：Different fasting time、dosing conditions and timing; Treatment group G：Fed conditions; Treatment group H：Fasting conditions

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The affiliated hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Qianqian Yang

CONTACT

+86 021-61053363; qianqian.yang.qy53@hengrui.com

Study Design

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

Model Details: Comparisons between arms with different dosing conditions, timing and food for oral HRS9531 tablets

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: August 5, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CN (1)