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This is a randomized, placebo-controlled, single ascending-dose (SAD) study of administered SC to adult subjects with elevated LDL-C. Subjects who have signed an Ethics Committee (EC)-approved informed consent form (ICF) and have met all the protocol eligibility criteria during screening may be enrolled into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Experimental | or placebo |
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| Cohort 2 | Experimental | or placebo |
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| Cohort 3 | Experimental | or placebo |
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| Cohort 4 | Experimental | or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RN0191 | Drug | This is a randomized, placebo-controlled, single ascending-dose (SAD) study of RN0191 administered SC to adult subjects with elevated LDL-C. Subjects who have signed an Ethics Committee (EC)-approved informed consent form (ICF) and have met all the protocol eligibility criteria during screening may be enrolled into the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of RN0191 administered as escalating single subcutaneous (SC) doses in adult subjects with elevated low-density lipoprotein-cholesterol (LDL-C) | This is a randomized, placebo-controlled, single ascending-dose (SAD) study of RN0191 administered SC to adult subjects with elevated LDL-C. Subjects who have signed an Ethics Committee (EC)-approved informed consent form (ICF) and have met all the protocol eligibility criteria during screening may be enrolled into the study. | For each subject in the study, the duration of the study clinic visits is approximately 18 weeks from screening to Day 85 EOS examination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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