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| Name | Class |
|---|---|
| AD Pharmaceuticals Co., Ltd. | INDUSTRY |
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This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK102 75mg | Experimental | AK102 75mg |
|
| AK102 150mg | Experimental | AK102 150mg |
|
| AK102 300mg | Experimental | AK102 300mg |
|
| AK102 500mg | Experimental | AK102 500mg |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK102 | Drug | AK102 single dose administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent AE | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. | From single dose of AK102 through 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic characteristics of AK102 | Serum concentrations of AK102 at different timepoints before and after AK102 single dose. | over 12 weeks |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Chen, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Drug | Placebo single dose administered subcutaneously |
|
Low-Density Lipoprotein Cholesterol (LDL-C) blood concentrations before and after AK102 single dose.
| At different time points from baseline through 12 weeks |
| Percent Change From Baseline in PCSK9 | PCSK9 blood concentrations before and after AK102 single dose. | At different time points from baseline through 12 weeks |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable ADAs. | At different time points from baseline through 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |