Safety and Pharmacokinetics of HRS-1597 Tablets in Healthy and Obese Participants: A Phase 1 Study

NCT07808918 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-1597-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese and Metabolic Disorders

Outcome Measures

Primary Outcomes (1)

• Safety: incidence of adverse event (AE), serious adverse event (SAE)

  10 days (SAD), 41 days (MAD)

Secondary Outcomes (10)

• 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

Study Arms (2)

single ascending dose (SAD) cohorts

EXPERIMENTAL

Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-1597 or placebo

Drug: HRS-1597; Drug: Placebo

multiple ascending dose (MAD) cohorts

EXPERIMENTAL

Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-1597 or placebo

Drug: HRS-1597; Drug: Placebo

Interventions

HRS-1597 DRUG

Specified dose on specified days

multiple ascending dose (MAD) cohorts; single ascending dose (SAD) cohorts

Placebo DRUG

Specified dose on specified days

multiple ascending dose (MAD) cohorts; single ascending dose (SAD) cohorts

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 55 years (inclusive), both male and female.
• 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).
• 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.

You may not qualify if:

• General Conditions:
• 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.
• History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture.
• 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.
• 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:
• 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.
• History of liver disease.
• History of diabetes or pre-diabetes.
• Diagnosis of malignancy or history of malignant tumors.
• 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:
• 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.
• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, 310000, China

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Zhang

CONTACT

0518-82342973; lei.zhang.lz177@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

CN (1)