Body Weight Management
Conditions
Brief summary
This study is a single-center, randomized, double-blind, dose-escalation, placebo-parallel-controlled Phase I clinical trial. The primary objective is to evaluate the safety and tolerability of a single subcutaneous injection of SHR-1179 in obese participants. For the single-ascending-dose (SAD) part in obese participants, a total of 5 dose cohorts are planned for the single-dose escalation.
Interventions
DRUGSHR-1179 ; Placebo
Dose 1 SHR-1179+Placebo low dose
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female participants aged ≥ 18 and ≤ 60 years at the time of informed consent signing; 2. Male participants weighing ≥ 50.0 kg, female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 28.0 and 35.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²); 3. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and Baseline. Female participants of childbearing potential or male participants with partners of childbearing potential must agree to avoid sperm/egg donation and practice highly effective contraception (including their partners) from the signing of the ICF until the completion of the safety follow-up period following the last dose (see Appendix 1); 4. Negative HIV antibody (HIV-Ab) test result at Screening; 5. Ability to understand the study procedures and requirements, willingness to participate voluntarily, and provide written informed consent.
Exclusion criteria
1. Have a documented history of diseases involving the immune system, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, etc., or other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this clinical trial (e.g., psychiatric history, etc.); 2. Have a history of drug or other allergies, or, in the investigator's judgment, may be allergic to the investigational product or any of its components; 3. Have undergone major surgery within 3 months prior to Screening, or have undergone surgery that may significantly affect the in vivo disposition of the investigational product or the safety evaluation, or plan to undergo surgery during the trial period; 4. Have participated in any clinical trial as a participant within 3 months prior to Screening, or plan to participate in other clinical trials during the course of this study; 5. Have experienced blood loss or donated blood \> 400 mL (excluding menstrual blood loss in females), received blood transfusion or blood products within 3 months prior to Screening, or plan to donate blood during the trial or within 1 month after the end of the trial. 6. Have experienced a body weight change of \> 5% within 3 months prior to Screening, or have used GLP-1 receptor agonists, weight-loss drugs, or systemic corticosteroids (oral or intravenous administration for more than 7 days) within 3 months prior to Screening; 7. Have any laboratory abnormalities meeting the following criteria at Screening, or have clinically significant abnormalities in vital signs, physical examinations, or laboratory tests specified in this protocol as judged by the investigator: 8. Have 12-lead electrocardiogram (ECG) findings at Screening showing atrioventricular block (excluding clinically insignificant first-degree atrioventricular block), atrial fibrillation, or atrial flutter, or QTcF ≥ 450 ms (males) or ≥ 470 ms (females), or other abnormalities judged by the investigator to be clinically significant; 9. Have chest X-ray (posteroanterior view) or abdominal ultrasound findings at Screening judged by the investigator to be clinically significant abnormalities; 10. Have positive results at Screening for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), or Treponema pallidum antibody (Anti-TP). 11. Have used or are currently using any prescription drugs or over-the-counter (OTC) medications within 2 weeks prior to dosing; or have taken functional vitamins, health supplements, or herbal products; or are known to require other medication during the trial period; 12. Have consumed excessive amounts of tea, coffee, or caffeinated beverages (average \> 8 cups per day, 250 mL per cup) within 3 months prior to Screening; 13. Have consumed special foods (e.g., grapefruit, grapefruit juice, or food/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated products, etc.) within 48 hours prior to dosing; 14. Have a history of regular alcohol consumption (i.e., \> 14 standard units per week within 3 months prior to Screening, where 1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirit, or 150 mL of wine), or are unable to abstain from alcohol during the trial; or have a positive alcohol breath test; 15. Have an average daily smoking history of \> 5 cigarettes per day within 3 months prior to Screening, or are unable to abstain from smoking during the trial; 16. Have been on a diet or received weight-loss treatment (for any reason) within 2 months prior to Screening, or have had significant changes in lifestyle habits; 17. Have a history of drug abuse or substance use; or have a positive result on drug abuse screening (including MDMA, methamphetamine, cocaine, morphine, ketamine, and THC acid); 18. Are pregnant or lactating females; 19. Have difficulty with venous blood sampling, are unable to tolerate venipuncture, or have a history of needle or blood phobia; 20. Have a history of severe cardiovascular disease, such as decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, myocardial infarction, or have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). 21. Participants who, in the opinion of the investigator, may be unable to complete the study for other reasons, or who are considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | from pre-dose to 10 months post-dose. |
Secondary
| Measure | Time frame |
|---|---|
| Serum concentration of SHR-1179 after single-dose administration. | from pre-dose to 10 months post-dose. |
| AUC of SHR 1179 after single administration（AUC0-last, AUC0-inf ） | from pre-dose to 10 months post-dose. |
| Time to peak concentration（Tmax） | from pre-dose to 10 months post-dose. |
| Peak concentration （Cmax） | from pre-dose to 10 months post-dose. |
| Elimination half-life （T1/2） | from pre-dose to 10 months post-dose. |
| Apparent clearance (CL/F) | from pre-dose to 10 months post-dose. |
| Apparent volume of distribution (V/F) | from pre-dose to 10 months post-dose. |
Countries
China
Contacts
CONTACTXuehu Gao, MD.
CONTACTHongda Lin, PhD.
Outcome results
None listed