A Phase I Study of SHR -2001 in Healthy Subjects

Launched by GUANGDONG HENGRUI PHARMACEUTICAL CO., LTD · Jul 4, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called SHR-2001 to see how safe it is and how it works in healthy adults. The study is looking for volunteers aged 18 to 55 who are generally healthy and meet certain criteria, like having a specific weight and body mass index (BMI). Participants will need to agree to follow the study rules and use reliable birth control methods if they are able to have children.

If you join this trial, you'll receive a single dose of SHR-2001, and the researchers will closely monitor your health to understand how your body reacts to the medicine. This is an early-stage study, so your participation will help scientists learn more about SHR-2001 and how it may be used in the future. It's important to note that certain health conditions or recent medical procedures might make someone ineligible to participate to ensure everyone's safety during the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
• • 2. Age 18 \~ 55 years old (including boundary value), male or female;
• • 3. Weight ≥ 45 kg, body mass index (BMI) ranging 19 \~ 28 kg/m2 (including boundary value);
• • 4. Participants who are overtly healthy as determined by medical history and physical examination.;
• • 5. Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.
• Exclusion Criteria:
• • 1. Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
• • 2. Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
• • 3. Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;