Atridia Pty Limited
Sydney, New South Wales, 2000, Australia
NCT Number: NCT04745104
A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Sydney, New South Wales, 2000, Australia
The study will consist of two parts: Subjects will be randomized to receive SHR-1707 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-1707 will be administered through IV infusion
Placebo will be administered through IV infusion
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Time to Cmax of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Maximum observed concentration of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Apparent clearance of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Apparent volume of distribution during terminal phase of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Terminal elimination half-life of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Mean residence time of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Change from baseline of plasma biomarker concentrations
Time frame: Start of Treatment to end of study (approximately 12 weeks)
The percentage of subjects with positive ADA titers over time for SHR-1707.
Atridia Pty Ltd.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707 in Healthy Young Adult and Elderly 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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