A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects
- Registration Number
- NCT04772365
- Lead Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Brief Summary
This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
- Be able to comply with all the requirements and able to complete the study.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.
- Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
- Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
- Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group B Placebo - Treatment group A SHR-1819 -
- Primary Outcome Measures
Name Time Method Adverse events Start of Treatment to end of study（about 13 weeks） Incidence and severity of adverse events
- Secondary Outcome Measures
Name Time Method Pharmacokinetics-Tmax Up to 13 weeks Time to Cmax of SHR-1819
Pharmacokinetics-CL/F Up to 13 weeks Apparent clearance of SHR-1819
Pharmacokinetics-Vz/F Up to 13 weeks Apparent volume of distribution during terminal phase of SHR-1819
Pharmacokinetics-AUC0-inf Start of Treatment to end of study (approximately 13 weeks) Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration
Pharmacokinetics-Cmax Up to 13 weeks Maximum observed concentration of SHR-1819
Change from baseline to end of treatment for Thymus and activation-regulated chemokine（TARC/CCL17） Up to 13 weeks Thymus and activation-regulated chemokine（TARC/CCL17）
Pharmacokinetics-AUC0-last Start of Treatment to end of study (about 13 weeks) Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration
Pharmacokinetics-t1/2 Up to 13 weeks Terminal elimination half-life of SHR-1819
Change from baseline to end of treatment for IgE Up to 13 weeks IgE
Immunogenicy of SHR-1819 after administration Up to 13 weeks] Anti-drug antibody
Pharmacokinetics- Ctrough for multi-dose Up to 13 weeks Minimum observed concentration of SHR-1819
Pharmacokinetics-AUCtau for multi-dose Start of Treatment to end of study (about 13 weeks) Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration
Pharmacokinetics- Racc for multi-dose Up to 13 weeks Accumulation ratio of SHR-1819
Trial Locations
- Locations (1)
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Changsha, China