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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1905 Dose Level 1 | Experimental | SHR-1905 Dose level 1 |
|
| SHR-1905 Dose Level 2 | Experimental | SHR-1905 Dose level 2 |
|
| SHR-1905 Dose Level 3 | Experimental | SHR-1905 Dose level 3 |
|
| SHR-1905 Dose Level 4 | Experimental | SHR-1905 Dose level 4 |
|
| SHR-1905 Dose Level 5 | Experimental | SHR-1905 Dose level 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905 | Drug | SHR-1905 will be injected subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Brisbane | Queensland | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39076593 | Derived | Fei Y, Li N, Qian W, Fan Y, Shen Y, Wang Q, McLendon K, Shen K. A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects. Front Pharmacol. 2024 Jul 15;15:1400696. doi: 10.3389/fphar.2024.1400696. eCollection 2024. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo | Drug | Placebo will be injected subcutaneously |
|
Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration
| Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-CL/F | Apparent clearance of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Anti-Drug antibody | The percentage of subjects with positive ADA titers over time for SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |