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.
Healthy male or female participants aged ≥ 18 and ≤ 60 years at the time of informed consent signing;
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);
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);
Negative HIV antibody (HIV-Ab) test result at Screening;
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.);
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;
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;
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;
Parallel
SHR-1179 ; Placebo
DrugDose 1 SHR-1179+Placebo low dose
SHR-1179 ; Placebo
DrugDose 2 SHR-1179+Placebo low dose
SHR-1179 ; Placebo
DrugDose 3 SHR-1179+Placebo medium dose
SHR-1179 ; Placebo
DrugDose 4 SHR-1179+Placebo high dose
SHR-1179 ; Placebo
DrugDose 5 SHR-1179+Placebo high dose
Adverse events
Serum concentration of SHR-1179 after single-dose administration.
AUC of SHR 1179 after single administration（AUC0-last, AUC0-inf ）
Time to peak concentration（Tmax）
Peak concentration （Cmax）
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
