A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses

September 21, 2026 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study

This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
        • Principal Investigator:
          • Qing Wen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
  2. The age range is from 18 to 55 years old (inclusive at both ends).
  3. Weight ≥ 50.0 kg.
  4. They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).

Exclusion Criteria:

  1. During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
  2. The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
  3. During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
  4. Diabetes (except gestational diabetes).
  5. Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
  6. Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial.
  7. Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result.
  8. Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration.
  9. Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
  10. Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-1596 Group

HRS-1596, healthy subjects or obese subjects.
Drug: HRS-1596

HRS-1596.
Placebo Comparator: HRS-1596 Placebo Group

HRS-1596 placebo, healthy subjects or obese subjects.
Drug: HRS-1596 Placebo

HRS-1596 placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of adverse events (AEs)
Time Frame: Screening period up to Day 84.
Screening period up to Day 84.

Secondary Outcome Measures

Outcome Measure
Time Frame
The maximum plasma concentration (Cmax)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Time to maximum plasma concentration (Tmax)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Terminal half-life (t1/2)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Anti-HRS-1596 Antibodies (ADAs)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Fasting plasma glucose (FPG)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 21, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-1596-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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