Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province
Jinan, Shandong, 250014, China
NCT Number: NCT04986540
This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250014, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: SHR-1906 IV, single dose
Drug: Placebo IV, single dose
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Area under the concentration-time curve from time 0 to last time point after SHR-1906 administration
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Area under the concentration-time curve from time 0 to infinity after SHR-1906 administration
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Time to Cmax of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Maximum observed concentration of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Clearance of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Volume of distribution during terminal phase of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Terminal elimination half-life of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
The percentage of subjects with positive ADA titers over time for SHR-1906
Guangdong Hengrui Pharmaceutical Co., Ltd
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 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.
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