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This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects. The study will be divided into the following parts:
Part A, conducted : SAD stage Part B, conducted: MAD stage There are 5 cohorts for the SAD escalation scheme. Dose escalation will start with the planned lowest dose 25mg,and the highest dose will be mainly determined based on the data obtained during the study process.
There are 3 cohorts for the MAD stage .The doses for these 3 cohorts are low dose, medium dose, and high dose, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RG002C0106 | Experimental | Randomly enrolled subjects receiving the investigational drug will receive subcutaneous injection for administration |
|
| placebo | Placebo Comparator | Randomly enrolled subjects receiving placebo will receive subcutaneous injection for administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG002C0106 | Drug | RG002C0106 is a siRNA drug targeting complement C3 to silence the related gene through the RNA interfering mechanism and inhibit the expression of C3 protein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug | Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug | up to 169 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 101125 | China |
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