A Phase I Study of SHR -2001 in Healthy Subjects
- Registration Number
- NCT05942612
- Lead Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Brief Summary
This study is a phase 1 single dose escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability,pharmacokinetics and Pharmacodynamics of SHR-2001 in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- 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;
- Age 18 ~ 55 years old (including boundary value), male or female;
- Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
- Participants who are overtly healthy as determined by medical history and physical examination.;
- 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
- Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 4 Placebo A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects Cohort 5 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects Cohort 5 Placebo A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects Cohort 6 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects Cohort 6 Placebo A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects Experimental: Cohort 7 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects Experimental: Cohort 7 Placebo A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects Cohort 2 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects Cohort 2 Placebo A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects Cohort 1 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects Cohort 1 Placebo A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects Cohort 3 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects Cohort 3 Placebo A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects Cohort 4 SHR-2001 A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects
- Primary Outcome Measures
Name Time Method Adverse events Start of Treatment to end of study (approximately 50 days) Incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics-Vz/F Start of Treatment to end of study (approximately 50 days)) Apparent volume of distribution during terminal phase of SHR-2001
Pharmacokinetics-AUC0-t: Start of Treatment to end of study (approximately 50 days) Area under the concentration-time curve from 0 to the last measurable time point after SHR-2001 administration
Pharmacokinetics-AUC0-inf： Start of Treatment to end of study (approximately 50 days) Area under the concentration-time curve from time 0 to infinity after SHR-2001 administration
Pharmacokinetics-Tmax： Start of Treatment to end of study (approximately 50 days) Time to Cmax
Anti-Drug antibody Start of Treatment to end of study (approximately 50 days) The percentage of subjects with positive ADA
Pharmacokinetics-Cmax： Start of Treatment to end of study (approximately 50 days) Maximum observed concentration of SHR-2001
Pharmacokinetics-t1/2： Start of Treatment to end of study (approximately 50 days) Terminal elimination half-life of SHR-2001
Pharmacokinetics-CL/F Start of Treatment to end of study (approximately 50 days)) Apparent clearance of SHR-2001
Trial Locations
- Locations (1)
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China