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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-9531 Tablet

    Drug

    HRS-9531 tablet.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Multiple ascending dose groupExperimental treatment 1 intervention
Group B: Single ascending dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau)

Time frame
From Day 14 to Day 15.
2

Adverse event (AE)

Time frame
Screening period up to Day 35.
3

Serious adverse event (SAE)

Time frame
Screening period up to Day 35.

Secondary outcomes

1

The maximum plasma concentration (Cmax)

Time frame
On the 35th day after continuous administration.
2

Time to maximum plasma concentration (Tmax)

Time frame
On the 35th day after continuous administration.
3

Area under the concentration-time curve (AUC)

Time frame
On the 35th day after continuous administration.
4

Time to maximum plasma concentration (Tmax)

Time frame
Post-dose from Day 1 to Day 183.

Other outcomes

Sponsors and contacts

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