A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR 3201 Injection in Healthy Participants

You may qualify if

• Healthy male or female participants aged 18 to 60 years (inclusive) at the time of informed consent signing;
• Male participants weighing ≥ 50.0 kg, and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive), where BMI = weight (kg) / height² (m²);
• Female participants of child bearing potential shall agree to contraception and oocyte donation avoidance from ICF signature to 6 months after last investigational product dose, with negative serum pregnancy tests at screening and baseline. Male participants shall agree to highly effective contraception and sperm donation avoidance from ICF signature to 6 months after last investigational product dose;
• Ability to understand the study procedures and requirements, willingness to participate voluntarily, and provide written informed consent.

You're excluded if

• Participants with past or current acute or chronic disorders of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems or metabolic abnormalities, as assessed by the Investigator to be unsuitable for study enrollment;
• 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 6 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;
• 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;
• Cannot tolerate MRI or have MRI contraindications, including but not limited to cardiac pacemaker, defibrillator, artificial heart valve or other metallic implants; or other conditions assessed by the Investigator that may cause potential risks during MRI scanning;
• Have any laboratory abnormalities at screening, or have clinically significant abnormalities in vital signs, physical examinations, or laboratory tests specified in the protocol as judged by the investigator;
• Have chest X-ray (posteroanterior view) or abdominal ultrasound findings at Screening judged by the investigator to be clinically significant abnormalities;
• 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);
• 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;
• Have consumed excessive amounts of tea, coffee, or caffeinated beverages (average > 8 cups per day, 200 mL per cup) within 3 months prior to screening;
• 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;
• 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 285 mL of beer, 25 mL of 40% spirit, or 85 mL of wine), or are unable to abstain from alcohol during the trial; or have a positive alcohol breath test;
• 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;
• Have a history of drug abuse or substance use; or have a positive result on drug abuse screening (including MDMA, methamphetamine, morphine, ketamine, and THC acid);
• Are pregnant or lactating females;
• Have difficulty with venous blood sampling, are unable to tolerate venipuncture, or have a history of needle or blood phobia;
• 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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-10-22