Obese and Metabolic Disorders
Conditions
Brief summary
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.
Interventions
DRUGHRS-1597
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This single-center, randomized, double-blind, placebo-controlled study comprises a single-ascending dose and food-effect part in 42 healthy participants, and a multiple-ascending dose part in 36 obese participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 to 55 years (inclusive), both male and female. 2. Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 19-26 kg/m² (inclusive). Part 2 (MAD): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 28-35 kg/m² (inclusive). 3. Male and female participants of childbearing potential and their partners agree to have no plans for pregnancy or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last dose, and voluntarily agree to use highly effective contraceptive measures. Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose (baseline period), and must not be lactating.
Exclusion criteria
\- General Conditions: 1. Smoking more than 5 cigarettes (or other nicotine-containing products) per day within 3 months prior to screening, or planning to use any tobacco products during the study period. 2. History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture. 3. Clinically significant abnormalities in physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, and coagulation function), chest imaging, abdominal ultrasound, or 12-lead electrocardiogram (ECG), as judged by the investigator. 4. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), syphilis antibody, or human immunodeficiency virus (HIV) antibody. History of Any of the Following Diseases or Conditions: 5. Suspected allergy to the investigational product or any of its components, or a history of severe allergy to any drug, food, toxin, or other exposure. 6. History of liver disease. 7. History of diabetes or pre-diabetes. 8. Diagnosis of malignancy or history of malignant tumors. 9. History of any clinically significant disease or condition that, in the investigator's opinion, may affect the study results, including but not limited to disorders of the circulatory, endocrine, neurological, digestive, urinary, hematopoietic, immune, psychiatric, or metabolic systems; or any condition that may affect the study results, drug absorption, distribution, metabolism, or excretion, or place the participant at undue risk. Current or Prior Use of the Following Medications: 10. Use of any prescription drugs, over-the-counter drugs (including natural health products, with the exception of routine vitamins), herbal medicines, or live (attenuated) vaccines within 1 month or 5 half-lives of the drug (whichever is longer) prior to baseline. 11. Refusal to abstain from any beverages or foods containing methylxanthines (e.g., coffee, tea, cola, chocolate, etc.) from 48 hours prior to baseline through the end of the study; refusal to abstain from any beverages or foods containing grapefruit from 7 days prior to baseline through the end of the study; or special dietary requirements that prevent compliance with a standardized diet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: incidence of adverse event (AE), serious adverse event (SAE) | 10 days (SAD), 41 days (MAD) |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of HRS-1597 in plasma and urine : Cmax | Days 1-34 |
| PK parameters of HRS-1597 in plasma and urine : Tmax | Days 1-34 |
| PK parameters of HRS-1597 in plasma and urine : AUC | Days 1-34 |
| PK parameters of HRS-1597 in plasma and urine : CL/F | Days 1-34 |
| PK parameters of HRS-1597 in plasma and urine : CLR | Days 1-34 |
| PK parameters of HRS-1597 in plasma and urine : Vz/F | Days 1-34 |
| PD endpoint (Fasting blood glucose)of HRS-1597 | Baseline-Day 34 |
| PD endpoint (Fasting serum insulin)of HRS-1597 | Baseline-Day 34 |
| PD endpoint (Fasting C-peptide)of HRS-1597 | Baseline-Day 34 |
| PD endpoint (HOMA-IR)of HRS-1597 | Baseline-Day 34 |
Countries
China
Contacts
CONTACTLei Zhang
Outcome results
None listed