Nucleus Network
Brisbane, Queensland, Australia
NCT Number: NCT04800263
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brisbane, Queensland, Australia
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SHR-1905 will be injected subcutaneously
Placebo will be injected subcutaneously
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 Treatment 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
Atridia Pty Ltd.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 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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