Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects

Official title

A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation

Overview

This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.

Interventions

• Drug HRS-9531 Tablet
  HRS-9531 tablet.

Primary outcome measures

• Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau) [Time frame: From Day 14 to Day 15.]
• Adverse event (AE) [Time frame: Screening period up to Day 35.]
• Serious adverse event (SAE) [Time frame: Screening period up to Day 35.]

Secondary outcome measures (4)

• The maximum plasma concentration (Cmax) [Time frame: On the 35th day after continuous administration.]
• Time to maximum plasma concentration (Tmax) [Time frame: On the 35th day after continuous administration.]
• Area under the concentration-time curve (AUC) [Time frame: On the 35th day after continuous administration.]
• Time to maximum plasma concentration (Tmax) [Time frame: Post-dose from Day 1 to Day 183.]

Eligibility criteria

Inclusion criteria

• Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
• Male subjects aged 18-55 years on the date of signing informed consent (inclusive);
• Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);
• The weight change within the previous 3 months should not exceed 5 kilograms.
• Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included.

Exclusion criteria

• Those who are known or suspected to be allergic to any component of the investigational drug or related products; or those who have a history of multiple or severe allergies to drugs or foods, or a history of severe immediate allergic reactions;
• Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;
• Having a history of hypertension or when the researchers determine during the screening that the blood pressure is abnormal and has clinical significance;
• Those with a history of obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), conditions that affect gastric emptying (such as pyloric stenosis), or who have undergone any gastrointestinal surgery (such as weight loss surgery; except for intestinal polyp resection and appendectomy), or who had acute diarrhea within the previous 7 days; diarrhea is defined as watery stools and/or more than 3 bowel movements per day;
• Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;
• Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;
• Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
• Those who have a history of drug abuse or drug use, or who have a positive result in the urine drug screening test during the screening period;
• Heavy drinkers (average weekly alcohol consumption of ≥ 14 units in the six months prior to screening: 1 unit of beer = 285 mL, or spirits = 25 mL, or wine = 100 mL; average daily smoking ≥ 5 cigarettes); those unable to quit smoking and drinking during the trial; those with positive alcohol blood tests.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital of Anhui Medical University — Hefei

Identifiers

NCT: NCT07150962 · HRS9531-T-103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗