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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1707 Dose level 1 | Experimental | SHR-1707 or placebo is administered intravenous to young healthy subjects |
|
| SHR-1707 Dose level 2 | Experimental | SHR-1707 or placebo is administered intravenous to young healthy subjects |
|
| SHR-1707 Dose level 3 | Experimental | SHR-1707 or placebo is administered intravenous to young healthy subjects |
|
| SHR-1707 Dose level 4 | Experimental | SHR-1707 or placebo is administered intravenous to young healthy subjects |
|
| SHR-1707 Dose level 5 | Experimental | SHR-1707 or placebo is administered intravenous to young healthy subjects |
|
| SHR-1707 Dose level 3 (Elderly subjects) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1707 | Drug | SHR-1707 will be administered through IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | 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) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atridia Pty Limited | Sydney | New South Wales | 2000 | Australia |
| 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 or placebo is administered intravenous to Elderly subjects |
|
| Placebo | Drug | Placebo will be administered through IV infusion |
|
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) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Pharmacokinetics-CL/F | Apparent clearance of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Pharmacokinetics MRT | Mean residence time of SHR-1707 | Start of Treatment to end of study (approximately 12 weeks) |
| Pharmacodynamics | Change from baseline of plasma biomarker concentrations | Start of Treatment to end of study (approximately 12 weeks) |
| Anti-Drug antibody | The percentage 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 |