The Third Xiangya Hospital of Central South University
Changsha, 410013, China
NCT Number: NCT04772365
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
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Changsha, 410013, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SHR-1819 will be subcutaneously administered with different dose levels;
Placebo will be subcutaneously administered with different dose levels;
Time frame: Start of Treatment to end of study(about 13 weeks)
Incidence and severity of adverse events
Time frame: 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
Time frame: 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
Time frame: Up to 13 weeks
Time to Cmax of SHR-1819
Time frame: Up to 13 weeks
Maximum observed concentration of SHR-1819
Time frame: Up to 13 weeks
Apparent clearance of SHR-1819
Time frame: Up to 13 weeks
Apparent volume of distribution during terminal phase of SHR-1819
Time frame: Up to 13 weeks
Terminal elimination half-life of SHR-1819
Time frame: Up to 13 weeks
Thymus and activation-regulated chemokine(TARC/CCL17)
Time frame: Up to 13 weeks
IgE
Time frame: Up to 13 weeks]
Anti-drug antibody
Time frame: 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
Time frame: Up to 13 weeks
Minimum observed concentration of SHR-1819
Time frame: Up to 13 weeks
Accumulation ratio of SHR-1819
Shanghai Hengrui Pharmaceutical Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07394127
Asthma, Asthma Chronic
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye)
View Trial DetailsNCT01678222
Allergic Inflammation, Asthma
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT03937804
Asthma, Bronchial Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial Details