Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT04905602
This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy subjects and subjects with mild asthma.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200031, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: SHR-1905 subcutaneous, single dose
Drug: Placebo subcutaneous, single dose
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Time to Cmax of SHR-1905
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Maximum observed concentration of SHR-1905
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Apparent clearance of SHR-1905
Time frame: Start of Treament to end of study (approximately 16 weeks)
Apparent volume of distribution during terminal phase of SHR-1905
Time frame: Start of Treatment to end of study (approximately 16 weeks)
Terminal elimination half-life of SHR-1905
Time frame: Start of Treatment to end of study (approximately 16 weeks)
The percentage of subjects with positive ADA titers over time for SHR-1905
Shanghai Hengrui Pharmaceutical Co., Ltd.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administered SHR-1905 in Healthy Subjects and Subjects With Mild Asthma.
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.
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