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
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
1 other identifier
interventional
122
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 21, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 25, 2026
September 1, 2026
3 months
September 21, 2026
September 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence and severity of adverse events (AEs)
Screening period up to Day 84.
Secondary Outcomes (5)
The maximum plasma concentration (Cmax)
Post-dose at Day 1 to Day 84.
Time to maximum plasma concentration (Tmax)
Post-dose at Day 1 to Day 84.
Terminal half-life (t1/2)
Post-dose at Day 1 to Day 84.
Anti-HRS-1596 Antibodies (ADAs)
Post-dose at Day 1 to Day 84.
Fasting plasma glucose (FPG)
Post-dose at Day 1 to Day 84.
Study Arms (2)
HRS-1596 Group
EXPERIMENTALHRS-1596, healthy subjects or obese subjects.
HRS-1596 Placebo Group
PLACEBO COMPARATORHRS-1596 placebo, healthy subjects or obese subjects.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- The age range is from 18 to 55 years old (inclusive at both ends).
- Weight ≥ 50.0 kg.
- 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).
You may not qualify if:
- During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
- The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
- 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.
- Diabetes (except gestational diabetes).
- 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).
- 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.
- 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.
- 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.
- Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
- Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinan Central Hospital
Jinan, Shandong, 250013, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
Study Record Dates
First Submitted
September 21, 2026
First Posted
September 25, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
September 25, 2026
Record last verified: 2026-09