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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single dose of SHR-1707 by intravenous infusion in healthy young adults. | Experimental |
| |
| placebo in healthy young adults. | Placebo Comparator |
| |
| A single dose of SHR-1707 by intravenous infusion in elderly subjects. | Experimental |
| |
| placebo in elderly subject | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1707 | Drug | A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration | Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration | Start of Treatment to end of study (approximately 12 weeks) |
| Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39390616 | Derived | Yang Y, Qiu H, Fan Y, Zhang Q, Qin H, Wu J, Zhang X, Liu Y, Zhou R, Zhang Q, Ye Z, Ma J, Xu Y, Feng S, Fei Y, Li N, Cui X, Dong F, Wang Q, Shen K, Shakib S, Williams J, Hu W. Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies. Alzheimers Res Ther. 2024 Oct 10;16(1):218. doi: 10.1186/s13195-024-01584-8. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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SHR-1707 compared with placebo
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| Placebo | Drug | A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults. |
|
| SHR-1707 | Drug | A single dose of SHR-1707 by intravenous (IV) infusion in elderly subjects. |
|
| Placebo | Drug | A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects. |
|
Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration |
| Start of Treatment to end of study (approximately 12 weeks) |
| Time to Cmax (Tmax) of SHR-1707 | Time to Cmax of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Maximum observed concentration (Cmax) of SHR-1707 | Maximum observed concentration of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Terminal elimination half-life (t1/2) of SHR-1707 | Terminal elimination half-life of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Clearance (CL) of SHR-1707 | Clearance of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Volume of distribution (Vss) of SHR-1707 | Volume of distribution of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Mean residence time (MRT) of SHR-1707 | Mean residence time of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| The change from baseline in plasma Aβ40 and Aβ42 concentrations | The change from baseline in plasma Aβ40 and Aβ42 concentrations will be measured to determine the degree of change over time. | Start of Treatment to end of study (approximately 12 weeks) |
| Number of subjects with Anti-SHR-1707 antibodies | Number of subjects with positive ADA titers over time for SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |