A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country52 target enrollmentMarch 1, 2021

ConditionsAsthma

InterventionsSHR-1819 Placebo

DrugsSHR-1819 Placebo

Overview

Phase: Phase 1
Intervention: SHR-1819
Conditions: Asthma
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 52
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 1, 2021

End Date

December 10, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Arms & Interventions

Treatment group A

Intervention: SHR-1819

Treatment group B

Intervention: Placebo

Outcomes

Primary Outcomes

Adverse events

Time Frame: Start of Treatment to end of study（about 13 weeks）

Incidence and severity of adverse events

Secondary Outcomes

Pharmacokinetics-CL/F(Up to 13 weeks)
Pharmacokinetics-Vz/F(Up to 13 weeks)
Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 13 weeks))
Pharmacokinetics-Cmax(Up to 13 weeks)
Change from baseline to end of treatment for Thymus and activation-regulated chemokine（TARC/CCL17）(Up to 13 weeks)
Pharmacokinetics-AUC0-last(Start of Treatment to end of study (about 13 weeks))
Pharmacokinetics-Tmax(Up to 13 weeks)
Pharmacokinetics-t1/2(Up to 13 weeks)
Change from baseline to end of treatment for IgE(Up to 13 weeks)
Immunogenicy of SHR-1819 after administration(Up to 13 weeks])
Pharmacokinetics- Ctrough for multi-dose(Up to 13 weeks)
Pharmacokinetics-AUCtau for multi-dose(Start of Treatment to end of study (about 13 weeks))
Pharmacokinetics- Racc for multi-dose(Up to 13 weeks)