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The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablet, qd, oral administration for 28 days |
|
| test drug | Experimental | Proximod Tablets, 6mg and 12mg, qd, oral administration for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximod | Drug | Single and multiple-dose to establish the safety and PK profile |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Up to 64 days | |
| Time to peak plasma concentration (Tmax) | Up to 64 days | |
| The lowest plasma concentration (Cmin) | Up to 64 days | |
| Half-life (t1/2) | Up to 64 days | |
| Number of adverse events and number of participants with adverse events | Up to 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocyte count | Up to 64 days | |
| Percentage of CD3+CD4+ and CD3+CD8+ T cells | Up to 64 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Changchun | Jilin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39454617 | Derived | Zhang H, Li Q, Li C, Wu M, Chen H, Li Y, You F, Zhao Y, Jin J, Chen X, Ding Y. Evaluation of proximod, a selective agonist of sphingosine-1-phosphate receptor-1, in healthy volunteers and patients with rheumatoid arthritis: a phase 1, double-blind, randomised, placebo-controlled, ascending dose trial. Lancet Rheumatol. 2024 Dec;6(12):e837-e847. doi: 10.1016/S2665-9913(24)00199-1. Epub 2024 Oct 22. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo | Drug | Placebo controlled |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |