The second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
NCT Number: NCT04973189
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Hefei, Anhui, 230601, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults.
A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.
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)
Terminal elimination half-life of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Clearance of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Volume of distribution 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)
The change from baseline in plasma Aβ40 and Aβ42 concentrations will be measured to determine the degree of change over time.
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Number of subjects with positive ADA titers over time for SHR-1707
Shanghai Hengrui Pharmaceutical Co., 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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